output.csv

Question,Answer
,
 When was the Guidance for Industry and Food and Drug Administration Staff Document issued?," September 28, 2022"
 What is the Class II classification?, special controls
 What produces biased estimates of CADe positive and negative predictive value?, Enriching a CADe study with subjects having the abnormal condition
 What did FDA say about the changes to the device definition?, to exclude certain software functions
 What was the FDA guidance on Off-The-Shelf Software Use in Medical Devices?, Off-The-Shelf Software Use in Medical Devices
 What is the date of FDA's policy and interpretation of section 3060(a) of the Cures Act?," September 27, 2022"
 What is the name of the FDA guidance document that presents FDA’s approach to section 520(o)(2) of the FD&C Act?, Multiple Function Device Products: Policy and Considerations
 What is the draft of the Guidance for Industry and Food and Drug Administration Staff Document issued on?," September 27, 2019"
 What is the name of the division that handles digital health?, Division of Digital Health
 What is the docket number of FDA-2017-D-6294?, docket number
 What is the name of the office that provides the guidance?," Office of Communication, Outreach, and Development"
 What is the purpose of the Software Function?, Administrative Support
 What is the Software Function Intended to Serve as Electronic Patient Records?, Electronic Patient Records
 What may introduce bias into CADe performance?, Retrospective reading of image sets
 What does the guidance not establish any rights for?, any person
 What is the FD&C act?," Federal Food, Drug, and Cosmetic Act"
 What is the level of guidance made to the listed guidance documents?, Level 2 updates
 What is the name of the section in which the guidance document has been withdrawn?, Section IV.D
 What is the word that is used in Agency guidance?, should
 What amended section 201(h) of the FD&C Act to state that the term device does not include the software functions excluded pursuant to section 520(o)?, Section 3060(d) of the Cures Act
 What is the purpose of the term device?, administrative support of a health care facility
 What is the purpose of electronic patient records?," for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition"
 What is the name of the nonbinding recommendation?, Nonbinding Recommendations
" What is not intended to transfer, storing, converting formats, or displaying clinical laboratory test or other device data and results?"," findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device"
 What refers to the reference standard misclassifying some subjects as having or not having the condition?, Imperfect reference standard bias
 What section of the FD&C Act describes limited circumstances when software functions described in 5 are not met?, Section 3060
 What is often referred to as clinical decision support software?, clinical decision support software
 What is the definition of a software function?, not a device
 What is the Cures Act's definition of a software function?, section 520(o)(1)(A) – (D)
 What did Section 3060 of the Cures Act create?, a function-specific definition
 What does not include a software function that is intended for administrative support of a health care facility?, device
 What is the section titled that provides additional clarity for software functions?, Section 3.2.2.
 What is LIS?, Laboratory Information Systems
 What is a software function that analyzes medical device data in order to provide a notification or flag?, that a parameter is out of range
 What is the risk to the safety of users and other persons?, low risk
 What can produce potential sources of statistical bias?, The study design of a retrospective reader study
 What does Section 520(o)(1)(B) of the FD&C Act affect?, two categories of general wellness intended uses differed
" What is not a device as long as its claims are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease?", a software function with a healthy lifestyle claim
 What does Section 520(o)(1) of the FD&C Act describe?," software functions, not hardware products"
 What does FDA intend to apply to hardware products that otherwise meet the definition of a device?, considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA
 What is the purpose of the software function?, Helping to Reduce the Risk or Impact of Certain Chronic Diseases or Conditions
 What is not excluded from the definition of device as modified by this new provis?, these products
 What is the purpose of the second category of general wellness intended uses?, help reduce the risk of or help living well with certain chronic diseases or conditions
 What is the purpose of a mobile application that only monitors and records daily energy expenditure and cardiovascular workout activities?, to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health.”
 What is the purpose of a software function?,
 What is the purpose of a software function?," alert the user, health care provider, or family member of unhealthy dietary activity"
 What is the name of the Appendix A of the MMA Guidance?, Examples of mobile apps for which FDA intends to exercise enforcement discretion
 What is the first read in the sequential reading design?, unaided by CADe
 What does the FD&C Act do to the mobile apps?," o Provide tools to promote or encourage healthy eating, exercise, weight loss, or other activities generally related to a healthy lifestyle or wellness"
 What does fda.gov provide for a baby?, policy-device-software- functions-and-mobile-medical-applications
 What does a software function serve as?, Electronic Patient Records
 What is not a device if all three criteria outlined in section 520(o)(1)(C)(i) – (iii) are met?," software functions that are intended to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart"
 What is the name of the section that certifies records in the ONC Health IT Certification Program?, 3001(c)(5) of the Public Health Service Act
" What is not intended for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition?", medical image data
 What is the name of the list of health information technology certified under the ONC Health IT Certification program?, Certified Health IT Product List
 What is a PHR not intended for?," diagnosis, cure, mitigation, prevention, or treatment of a disease or condition"
 What does FDA not intend to enforce compliance to at this time for software functions that are not certified under the ONC Health IT Certification Program?, compliance to the requirements of the FD&C Act
 What is not required for ONC certification of these PHR software functions?, ONC certification
" What is another concern is that a reader may undercall the unaided reading relative to the reading aided by CADe, producing an enhanced CADe effect?",
 What is the FDA's approach to oversight of software?, FDA’s approach to oversight of software functions that meet the definition of a device in a system with software functions that do not meet the definition of device (products with multiple functions) will be addressed in a separate guidance document.
 What is the name of the section that describes examples of mobile apps for which FDA intends to exercise enforcement discretion?, Section V.B
 What are these software functions that provide individuals with access to?, health record systems or enable them to gain electronic 13 “Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C Act) 14 Available at https://www.fda.gov/regulatory-informatio Answer: Answer:: Answer:::::::::::::::::::::::::::::::::::::: (A) exercise enforcement discretion as to any device subject to regulation under this Act . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 What is the name of the category that Contains Nonbinding Recommendations access to health information stored within an EHR system?, Nonbinding Recommendations
 What is the name of the act that amends the FD&C Act?, Cures Act
 What does FDA not intend to enforce compliance with?, requirements of the FD&C Act that apply to these software functions
 What does the Mobile apps provide patients with to organize and track their health information?, simple tools
 What are apps that provide simple tools for patients with specific conditions or chronic disease?, o Apps
 What does the videoconferencing portals enhance?," communications between patients, health care providers, and caregivers"
 What is a sub-bullet's functions beyond?," transfer, store, convert formats, or display the equivalent of a paper medical chart"
 How many independent reading sessions are there?, two
 What is the phrase “that is [or are] certif?,” that is [or are] certif
 What is the name of the software function that allows a health care provider to access their patient’s personal health record?, Mobile apps
 What is the name of the document that helps track or manage patient immunizations?, documenting the need...
 What does the mobile app that helps asthmatics record inhaler usage do?, collect and log
 What does a clinician send a link to a patient to access after the visit?, the clinical conversation
 What is the name of the program that certifies electronic health records?, ONC Health IT Certification Program
" What is not a medical device because interacting with PHR or EHR systems is an example of transferring, storing, converting formats, or displaying EHR or PHR data?", interacting with PHR or EHR systems
 What is MDDS?," a software, electronic, or electrical hardware that is intended to provide one or more of the following uses, whether or not it is intended for imme"
 What is an example of a wireless MDDS?, physical communications medium
 What is a medical image communications device?, a device that provides electronic transfer of medical image data between medical devices
 What is read in reading session 2?, the cases are “crossed over” to the other modality
 What is MDDS?, medical image storage devices
 What is the purpose of software functions?," to transfer, store, convert formats, and display medical device data and results"
 What does Section 520(o)(1) of the FD&C Act describe?," software functions, not hardware products"
 What is the hardware function limited to assisting?," electronic transfer, storage, conversion of formats, or display of medical device data"
 What is not excluded from the device definition by the Cures Act?, Such medical display hardware devices and other specialized medical display hardware integral to a medical device
 What does FDA not regulate in a MDDS multiple function product?, MDDS software functions that meet the definition of 520(o)(1)(D) of the FD&C Act
 What does FDA want to provide on the regulation of multifunctional devices?, guidance document
 What is general-purpose hardware IT infrastructure intended for?, data transfer
 What is not regulated as devices?, display of data (computer monitor)
 What is a software function intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays?, alarms or alerts
 What is the name of the journal that studies the impact of prevalence and case distribution in diagnostic imaging studies?, Journal of Medical Imaging
 What is not excluded from the definition of device under subsection (D)?, software functions that analyze medical device data in order to provide a notification or flag
" What has been revised to clarify that software functions that are solely intended to transfer, store, convert formats, and display medical device data and results are not devices and thus are not subject to FDA regulatory requirements?",
 What has the definition of MDDS been revised to describe?," hardware that transfers, stores, converts formats, and displays medical device data"
 What is the term for the electronic storage and retrieval of medical device data?, The electronic storage and retrieval
 What is a software that converts digital data generated by a pulse oximeter into a digital format that can be printed?,
 What is a nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco?,
 What has been removed from this example?, hardware
 What is written by entities other than the original medical device manufacturer?, Custom software
 What is not considered MDDS when modifying software for MDDS functionality?, the original software is not
 What is the compliance policy of FDA for Medical image storage devices?, 21 CFR 892.2010
 What is the purpose of the Policy section?, to remove reference to software functions that are not device functions
 What is the purpose of the guidance document?, for comment purposes only
" What is the purpose of hardware that is intended to transfer, store, convert formats, and display medical device data and results remain devices?", devices
 What is the name of the app that displays medical images directly from a Picture Archiving and Communication System (PACS) server?, software function
 What is the Appendix B of the MMA Guidance intended to be used for?, Examples of mobile apps for which FDA intends to exercise enforcement discretion
" What is a function that displays, displays, or displays medical device data without modifying the d?"," Software functions that transfer, store, convert formats, and display medical device data"
 What do software functions that meet the definition of MDDS connect to?, a nursing central station
 What has been replaced with “software functions” to clarify that the software functions are Non-Device-MDDS?, mobile apps
 What does the Mobile apps connect to?, bedside (or cardiac) monitors
" What does DRT, MWI, MSX stand for?", 21 CFR 870.2300
 What is a Mobile apps that are intended to display images for diagnostic review regulated as?, picture archiving and communications system
 What is the definition of Medical Device Data Systems?,
 What is the definition of Medical Device Data Systems?, Software functions that are intended to Answer: These are software functions that are intended to Answer: Answer: These are software functions that are intended to Answer: Answer: These are software functions that are intended to Answer: Answer: These are software functions that meet the definition of Medical Device Data Systems
 What is the final rule for Medical Device Classification Regulations?, Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
 What is the name of the docket that publishes in the Federal Register?, docket number
 What does the software functions in this example include?," those software functions for a secondary display to a regulated medical device when these apps are not intended to provide primary diagnosis, to be used to make treatment decisions, or to be used in connection with active patient monitoring."
 What has been withdrawn because some software functions no longer meet the definition of a device?, Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
 What is the name of the document that was written in 2000 that is out of date?, ISO 10993-1
 What is the name of the document that supersedes the use of International Standard ISO 10993-1?," ""Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"""
 What is the name of the U.S. Department of Health and Human Services Center for Devices and Radiological Health Center for Biologics Evaluation and Research?, Food and Drug Administration
 What is the name of the office that the FDA sends comments to?, Dockets Management Staff
 What is the name of the office that provides the guidance for biologics?, Center for Biologics Evaluation and Research
 What is the scope of the ISO 10993 part?, 2 III. Risk Management for Biocompatibility Evaluations
 What is the name of the Attachment that contains Device Master Files for Biocompatibility Evaluations?, Attachment B: Device Master Files for Biocompatibility Evaluations
 What is the name of the biocompatibility evaluation Flow Chart that is attached to the Summary Biocompatibility Documentation?, Biocompatibility Evaluation Flow Chart
 What is the name of the U.S. Department of Health and Human Services Center for Biologics Evaluation and Research?, CBER
 What are the types of Devices included?, Which Types of Devices are Included
 What is the name of the international standard used for the evaluation of medical devices?, ISO 10993-1
 What can you use if it satisfies the requirements of applicable statutes and regulations?, an alternative approach
 What is the purpose of this guidance?," to provide further clarification and updated information on the use of International Standard ISO 10993-1, ""Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk Answer: Evaluation and testing within a risk"
" What is the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations?", the use of risk-based approaches
 What should the sponsor specifically state when assessing new devices?, if the device does not have any direct or indirect tissue contact
 What should be done if the change could affect other parts of the device with direct or indirect contact that were not changed?, a biocompatibility evaluation
 What is the current edition of the FDA-recognized consensus standard(s) referenced in this document?, FDA Recognized Consensus Standards Database
 What do FDA guidances describe?, the Agency's current thinking on a topic
 What is the only non-contact device that has no direct or indirect contact with the body?, software
 What is the name of the U.S. Department of Health and Human Services Center for Biologics Evaluation and Research?, CBER
 What is the name of the series of standards that are not bound by the ISO4 10993?, ISO4 10993
 What is the ISO 10993-1 used for?, to determine the relevant biocompatibility endpoints for an evaluation
 What does ISO stand for?, International Organization for Standardization
 What stands for Organisation for Economic Co-operation and Development?, OECD
 What is Attachment F: Component and Device Documentation Examples?, outlines example documentation language that we recommend using when comparing the composition of a test article to the composition of a finished medical dev
 What does Attachment H describe?, terms and definitions used in this guidance
 What should be followed in some cases?, biocompatibility recommendations in the device-specific standard should be used instead of the recommendations outlined in ISO 10993- 1
 What is the reason for subcomponent testing of hemodialyzers?, high surface area of the membrane component
 What is the purpose of ISO 10993-12 recommendations?, if non-membrane components are tested separately
 What may be needed if additional or modified testing is needed?, additional or modified testing
 What is the simplest way to identify information gaps in an IND?, Bridging Within an IND from a Drug Developed in a Prefilled Syringe to a Drug Developed in an Autoinjector
 What is the FDA's Guidance for Industry and Food and Drug Administration Staff?,appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
 What is the term used in the definition of a combination product?, may
 What will the final determination on whether additional information should be provided depend on?, the specifics of the final device under consideration
 What is the name of the Supplemental Information Sheets published on the FDA website?, Supplemental Information Sheets
 What is the name of the document that should be provided when a declaration of conformity is submitted?, a copy of the supplemental information used to support the declaration
 What is the result of the DA recognized biocompatibility standards?, significant changes to the recommendations in this document
 What is the name of the guidance available at https://www.fda.gov/regulatory-information/search-fda-guidance- documents/requesting-fda-feedback-combination-products 16See FDA’s Database on Recognized Consensus Standards?,
 What is the name of the FDA's biocompatibility testing program?, ASCA
" What would be acceptable if it is easier for the sponsor to submit a copy of the test report, which is not required by FDA?", this would be acceptable
 What should be the first step in the biological evaluation of a medical device?," assessment of the device, including the material components, the manufacturing processes, the clinical use of the device including the intended anatomical location, and the frequency and duration of exposure"
 What is the draft guidance for Biologic-Device Combination Products called?, Bridging of Data
 What could alter the physicochemical characteristics of the device?, aspects of manufacturing and processing
 What should be considered in the appropriate benefit-risk context?, The interpretation of the overall biocompatibility evaluation
" What should the risk assessment evaluate not only the materials used in the device, but also the processing of the materials, the manufacturing methods (including the sterilization process), and any residuals from manufacturing aids used during the process.?",
 What should also consider which material components of the device have direct or indirect contact with tissue?, potential exposure duration
 What can be demonstrated by bench testing?, the pulse generator is hermetically sealed and will limit exposure of those chemicals to the surrounding tissues
" What can surface properties, forces on surrounding tissue, geometry, and presence of particula contribute to?", an unwanted tissue response
 What might the original processing for an implanted device include placing the device in to facilitate passivation of the implant surface?, an acid bath
 What could result in pyrogenic reactions (fever) following implantation of the device?, implantation
 What is another source of information on potential biocompatibility risks?, reported experience from other manufacturers using the same material in the same or similar anatomical location
 What can information on potential for irritation or sensitization be useful for?, risk assessment
 What is not binding on FDA or the public?, It does not establish any rights
 What is more applicable for a vascular catheter comprised of a certain polymer?, citing experience with the same polymer in a blood-contacting device
 What is useful if it includes information on recommended processing of the material or component and any biological?, A master file
 What should a master file also contain?, a risk assessment provided by the supplier
 What can be particularly helpful to demonstrate that chemical toxicity testing from a previ?, Chemical analysis
 What can demonstrate that the extractables and leachables in a biocompatibility extract have not changed?, a chemical analysis
 What can be used to evaluate potential carcinogens?, Extraction techniques
 What could affect the biological response in certain scenarios?, device geometry
 What may be insufficient due to the potential for chemical interactions between the material and added chemical?, individual toxicity information
 What should be included in your ri?," what is known about the additional material, the base material, and potential chemical interactions between the two"
 What can be used to assess some biocompatibility endpoints?, Threshold of Toxicological Concern
 What is the BLA for drug- 21 device and biologic-device single entity?, single entity
 What could literature inform manufacturers about?, nitinol passivation of a peripheral stent
 What should Sponsors be selective in how literature and other publicly available information are used to inform their risk assessment?, how literature and other publicly available information
 What may not be appropriate to extrapolate use in food to device-specific tissue contact?,
 What should sponsors also evaluate when considering available literature with respect to specific device materials?, whether such information is relevant in light of the manufacturing and processing for the medical device
 What does the 3Rs stand for?, 3Rs
 What is the name of the study that focuses on the use of TTC and SAR modeling?, Assess and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
 What should the submission include information on if literature is used in lieu of testing for certain biocompatibility endpoints?," applicability of the dose, route, and frequency of exposure from the literature report(s) as compared to the proposed device use"
 What is LOAEL?, Lowest Observed Adverse Effect Level
 What may be used to assess the potential reproductive toxicity of compounds released from devices that are not in direct contact with reproductive tissues?, NOAEL/LOAEL values
 What may not be necessary if the patient’s life expectancy in the intended use population is limited?, testing to address long-term biocompatibility endpoints
 What may result in symptoms that are indistinguishable from the disease state such that the clinical data may not be informative to the biocompatibility evaluation.?,
 What is the definition of combination products in 21 CFR 3.2?, combination products
 What may not be necessary if there is previous clinical experience with a particular medical device?, biocompatibility testing for complement activation
 What did some clinical studies of specific absorbable medical devices demonstrate?, that the absorption kinetics were not accurately
 What has this information been helpful for evaluating?, a next generation device using an improved bench model for the absorption of the device
 What could affect the final chemistry of an implant made from the same material?, manufacturing and processing
 What should be included in the in vivo animal study design with an appropriate study endpoint?," in vivo thrombogenicity, and acute, subchronic, and chronic toxicity"
 What may show toxic effects in animal studies?, glutaraldehyde-fixed tissue heart valves
 What is the name of the IDE that is used to review devices granted Breakthrough designation?, Early Feasibility Study
 What is the name of the Guidance for Industry and Food and Drug Administration Staff?, Breakthrough Devices Program
 What would trigger the need for additional studies?, These findings would usually trigger the need for additional studies
 What has FDA not found to provide relevant biocompatibility information?, animal data
 What is the ent part definition in 21 CFR 4.2?, 21 CFR 4.2
 What would not typically include assessment of biological response?, animal studies
 What can be a starting point for FDA's review?, Standards that address bulk material composition
 What is the effect that manufacturing and processing may have on a polymer?, incorporated into the final finished medical device
 What are other materials that have been reviewed by FDA also relevant for consideration as part of a risk assessment?, Experience with medical device materials
 What should Sponsors be specific in when referencing devices previously reviewed by FDA?, their risk assessment
 What should a sponsor clearly summarize in a submission?, their conclusions regarding their risk asse
 What should the sponsor identify to mitigate any remaining risks?, biocompatibility testing or other evaluations
 What might provide additional context for interpretation?, results of in vivo animal studies
 What should be evaluated considering the intended use of the device and as part of the overa?, potential toxicities identified through biocompatibility testing
" What is the ISO/TS 10993-19 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials?", ISO/TS 10993-19
 What is the name of the section that applies to products submitted for licensure under the PHS Act?, 351(k)
 What does Attachment C provide an example biocompatibility risk assess?, an example biocompatibility risk assess
 What does FDA review risk assessments as part of?, overall biocompatibility evaluation
 What is the most common way to discuss a risk assessment with FDA?, discuss the planned approach
" What is needed when questionable or inconclusive findings have occurred in any previously conducted biocompatibility evaluations, or in the event that novel materials are used?",
 What is the hemical analysis protocol used for?, to simulate patient exposure to medical device materials over time
 What should sponsors understand about each component of a medical device?, biocompatibility
 What is the purpose of the mention of Novel materials in this document?, to provide transparency regarding FDA’s current thinking and recommendations regarding biocompatibility evaluation of devices made from these materials
 What is needed to determine if a metal stent has a polymer coating that may separate over time?, biocompatibility evaluation
 What is performed to determine the acceptability of any potential adverse biological response resulting from contact of the component materials of the device with the body?, Biological evaluation of medical devices
 What is the purpose of systematic analysis of a new device intended for human use?, ensure that the benefits provided by the device in its final finished form will outweigh any potential risks produced by device materials over the inte
 What does this document provide guidance regarding?," clinical performance assessment studies for CADe devices applied to radiology images and radiology device data and CA Answer: The use of the word should in Agency guidances means that something is suggested or recommended, but not required"
 What is the term used to refer to the process of establishing the scientific relevance of information developed in an earlier phase of the development program or 34 another development program to support the combination product for which an applicant is seeking approval?, bridging
 What should be considered when selecting the appropriate endpoints for biological evaluation of a medical device?," in vitro cytotoxicity; acute, subchronic and chronic toxicity; irritation; sensitization"
 What is not sufficient to demonstrate the safety of certain devices?, biocompatibility endpoints identified in Attachment A
 What are two biocompatibility endpoints?, neurotoxicity and immunotoxicity
 What is the stiffness required for the device to perform appropriately?, stiffness
 What is a material that could impact the biological response to the device?, hydrophilic or hydrophobic surface
 What is a sponsor of a legally-marketed device able to explain?, why manufacturing is
 What may Sponsors leverage information from existing marketing applications to support a rationale that the biocompatibility of the device has been established?, Sponsors may also leverage information from existing marketing applications
 What does Part 1 of the ISO 10993 standard provide a framework for?, biological evaluation of medical devices
 What did the focus of the document change from?," how to determine which biocompatibility tests to conduct, to an approach that considers existing information prior to determining if biocompatibility testing is needed"
 What is the purpose of leveraging information from other marketing applications?," 510(k)s, PMAs, De Novos, HDEs, and initiation of IDEs"
 What must an applicant bridge to leverage the information from an earlier phase of the development program?, current application
 What is the part of ISO 10993-1 that is used for the evaluation of medical devices?, Evaluation and testing within a risk management process
 What should chemical formulation for each component material take into account?, likelihood of direct or indirect tissue contact
 What may not be sufficient to establish the biocompatibility of the device?, this information alone may not be sufficient
 What should be considered for their relevance to the overall biocompatibility evaluation of the device?," The material(s) of manufacture, the device in its final finished form, and possible leachable chemicals or degradation products"
 What should be done to devices to facilitate the selection of appropriate endpoints for inclusion in the overall biocompatibility evaluation?, categorization
 What does the FDA not recognize?, ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
 What should also be provided if a study was not conducted in compliance with the GLP Regulations?, a statement in your submission explaining the reasons why the study was not in compliance with the GLP Regulations
 What should be submitted to the reviewing authority when test data are provided?, complete experimental data
 What should be evaluated with respect to possible changes in biocompatibility?," physical configuration (e.g., size, geometry, surface properties) or intended use of the device"
 What does the FDA-Modified Matrix outline?, recommendations for biological effects evaluation
 What is assumed that the 44 applicant owns or has a right of reference or use that allows the applicant to use information 45 from another development program?, the applicant
 What is the definition of nonclinical laboratory study at 21 CFR 58.3(d)?, definition of nonclinical laboratory study
 What is the main benefit of a pacemaker?," If the device has multiple types of exposure, you should include information to address each exposure category identified for the device"
 What framework does FDA agree with?, ISO 10993-1
 What may not be relevant for all devices?, All biological effects included in the matrix
 What information may not always be needed for all submissions of medical devices?, Chemical formulation and processing information
 What should the comparator device be demonstrated to be?, “worst case”
 What may be of limited utility if specific biocompatibility endpoints are not included as part of the data collected for these studies?, In vivo animal data and/or clinical data
 What is the category of the device type?, nature of body contact
 What can differences in the final finished form of a medical device affect?, biocompatibility
 What should undergo the same manufacturing and sterilization processes?, representative test article
 What applies to the following: 53 54 • Human prescription combination products that are the subject of an investigational new 55 drug application (IND) under 21 CFR part 312?,
 What could occur when all of the components are tested within a medical device in its final finished form?, a more robust tissue response
 What may be appropriate to demonstrate that the surfaces are equivalent in geometry and surface properties?, extraction and surface characterization techniques
 What is the FDA's recommendation for test article preparation?, representative of the device in its final finished form
 What is the purpose of using in vitro degradation methods?, biocompatibility assessment
 What may not be acceptable depending on the materials of manufacture and the degradation testing conditions?, accelerated degradation testing
 What should be targeted to demonstrate?, how the device materials degrade over time
 What is the purpose of chemical analytical testing of the extract?, to determine whether the extract is representative of leachables during the polymerization or degradation processes
 What is the scope of ISO 10993-1?, includes biological hazards arising from Device Mechanical Failure
 What is it possible that mechanical failure could alter?, biological response to the device
 What could change with mechanical loading?, surface topography
 What is the scope of the 505(b)(2) guidance?, discussion of those considerations
 What could result in nickel?," non-optimized passivation layers that can be further compromised by mechanical loading, such as during device placement"
 What can be unique properties associated with submicron or nanotechnology components?, submicron ( 1 micron) or nanotechnology compon
 What is the purpose of ISO 10993-12 test conditions?, analysis of submicron component biocompatibility assessments
 What should you select to avoid testing artifacts?," extract conditions (e.g., solvent type)"
 What is the context of contemporary literature regarding the validity of individual tests for assessment of devices with submicron components?, standard biocompatibility tests
 What is the assurance that the submicron components will not interfere with the conduct of a chosen test?, Assurance that the submicron components will not interfere
 What is the appropriate amount of test article?, ISO 10993-12
 What should be provided if there is a need for an alternate extraction ratio?, appropriate justification
 What should be noted in the test report if the recommended surface area to extract volume cannot be achieved?, fluid contacting surface area and extraction volume
 What is the appropriate mixed polarity solvent for extracting both hydrophilic and lipophilic chemicals?, cell culture medium with 5-10% serum
 What is the most recent version of a guidance?, FDA guidance web page
 What is a test that requires intravascularly a polar extract?, material-mediated pyrogenicity
 What are traditional biocompatibility extraction methods?, ISO 10993-12:2021
 What may devices that contain heat labile or heat sensitive materials have the potential to undergo deformation or material configuration/structural change at high temperature?," drugs, biomolecules, tissue-derived components"
 What is the recommended temperature for xtraction?, 37 °C
 What is the maximum duration of contact a device can have with it?, 30 day
 What is the purpose of testing new materials separately?, to further understand the potential toxicity of this component
 What should you consider when conducting any of the tests identified below?, the following issues
 What percentage of serum is used in MEM?, 5-10%
 What is the purpose of a non-standard direct contact study?, where the cells are grown on a material surface
 What terms are used interchangeably and also refer to biological products and biological product constituent parts?, drug and drug constituent part
 What is the level at which cytotoxicity no longer occurs?, level
 What is the Local Lymph 25 Contains Nonbinding Recommendations Node Assay?, sensitization tests
 What is the ISO 10993-10?, Buehler method
 How many animals do we recommend that positive control testing include?, a minimum of five animals
 What is the reason for repeating positive control testing to justify a failed positive control test?, there is no assurance that the test system is working appropriately
 What is the purpose of LLNA?, evaluate use of LLNA tests for medical devices on a case-by-case basis for medical devices
 What is the exception to the LLNA testing?, nickel-containing metals
 What does the standard state about nsitization?," a positive control does not need to be included in every assay, but may be run at regular intervals which shall not exceed six months"
 What can be used to test device materials in aqueous solutions?, The LLNA
 What is the most important thing to use to achieve adequate exposure?, positive control results
 What does FDA encourage applicants to contact to discuss specific information needed to support their individual applications?, FDA
 What is unknown in an LLNA test?, whether chemicals will be able to penetrate the skin
 What is the LLNA: 2-Bromodeoxyuridine-Enzyme Linked Immunosorbent Assay (BrdU-ELISA) test or the LLNA: Daicel Adenosine Triphosphate (DA) test?,
 What is the potential for false positive results?, there is a potential for false positive results that could limit the usefulness of this type of LLNA test
 What is the potential for for borderline positive responses between an SI of 1.8 and 2.5?, false positive results
 What is the 1% pluronic L92 surfactant used for?, testing pesticide formulations
 What is the only way to determine if a device has indirect contact with circulating blood?, in vivo thrombogenicity testing
 What is not necessary when hemocompatibility testing is determined to be not necessary?, hemocompatibility testing
 What is the name of the standard practice for assessment of hemolysis?, ASTM F756 Standard Practice for Assessment of Hemo
 What is the only method that we recommend for hemolysis testing of devices having indirect contact with circulating blood?, indirect (extract) method
 What is an issue with high shear stress due to blood flow?, high shear stress
 What does the word should mean in Agency guidances?," something is suggested or recommended, but 81 not required"
 What is a complex process and is a function of physical and chemical properties of the device?, Medical device-mediated complement activation
 What is the most likely cause of a device having direct contact with blood?, complement activation
 What should be provided to confirm that the testing is capable of detecting differences between negative and positive reference controls. test validation information?,
 What is the legal name of the comparator device used for complement activation testing?, comparator device
 What can be used to test complement activation?, in vivo animal models
 What is the safety of cardiovascular stents?, is co Answer: the safety of cardiovascular stents is co
 What is the animal model used for the evaluation of mmonly?, an animal model
 What is the name of the 2010 J Immunol Methods article that describes the preparation of serum for functional complement assays?, 352 (1-2): 195- 197
 What should be used to minimize vessel trauma at the implant site?, implantation technique
 What is the purpose of explantation technique?, to ensure minimal disruption of adhered thrombus and to minimize post-mortem clot formation
" What are drugs, devices, and biological products constituent parts of?", a combination product
 What is a device that is not subject to in vivo animal studies?, oxygenators
 What is PTT?, Partial Thromboplastin Time
 What masks any activation caused by the device or its component materials?, the activating substances
 What is recommended for tests that require large blood volumes?, mmendations simulated clinical flow conditions
 What is the evaluation might include?, additional in vitro or in vivo testing
 What is an example of a non-anticoagulated animal study that may be needed in certain instances?," acute (e.g., four to six hours)"
 What may be necessary to screen for device-related characteristics?, surface defects
 What may also be beneficial in some cases?, a detailed analysis of your device geometry and surface as compared to a legally marketed device
 What is used to help protect pa?, pyrogen limit specifications
 What are chemicals that can leach from a medical device during device use?, material- mediated pyrogens
 What are CADe devices used for?," mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries"
" What is FDA committed to applying a 92 consistent, risk-based approach to address?", similar regulatory questions
 What is the USP 151> Pyrogen Test?, USP Rabbit Test
 What is the recommended temperature for t sensitive materials?, 37 °C
 What is the purpose of data regarding the thrombogenic potential of a device?, comparative purposes
 What is traditionally addressed as part of the sterility assessment?, Bacterial pyrogens
 What is an acceptable method for implantation testing if characteristics of the device geometry may confound interpretation of this test?, to use device sub-components or coupons
 What is the name of the part of ISO 10993-6 that describes the Biological evaluation of medical devices?, Part 6: Tests for local effects after implantation
 What can be assessed as part of in vivo animal studies?, overall device safety
 What is FDA’s guidance document called?, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
 What is the sterility guidance written to address?, sterility information for 510(k) submissions
 What is the FDA's guidance titled?, General Considerations for Animal Studies Intended to Evaluate Medical Devices
 What is the final rule on Postmarketing Safety Reporting for Combination Products published?," December 20, 2016"
 What is not needed when clinically relevant implantation studies are conducted?, Muscle or subcutaneous implantation tests
 What may result in an exaggerated response not observed in the site-specific implantation study?, any materials eluted over time from the test article may be contained within the capsule
 What should be considered even when clinically relevant implantation studies are performed?, muscle implantation studies
 What may be used to select interim assessment time points?, in vitro degradation testing
 What may be needed to demonstrate the risk of the known genotoxin?, Chemical characterization
 What is requested when the genotoxicity profile has not been adequately established?, Genotoxicity testing
" What is recommended because of the high surface area, the associated increased potential for chemical leaching, and introduction of any leachables into the systemic?", genotoxicity evaluations
 What is the test conducted with engineered strains of Salmonella typhimurium and Escherichia coli?,56  Bacterial gene mutation assay
 What is the preferred method for detection of genotoxic mechanisms?,
 What is the OECD 490 Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Gene Mutation Tests using the Thymidine Kinase Gene?, A choice of one of the following is recommended
 What is the OECD 487 Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Micronucleus Test?, in vitro micronucleus assay
 What may be leveraged to support approval of 98 the proposed combination product if an appropriate bridge can be established?, an 96 applicant has its own existing information (or rights of reference to information) about another 97 combination product or a proposed constituent part
 What is the test not need to be performed?, the test does not need to be performed
 What is the CA assay?, bone marrow chromosomal aberration
 What should be repeated in the event of an equivocal result in any of the in vitro assays?, the same assay should be repeated
" What should be performed on undiluted extracts only, unless cytotoxicity is shown to interfere with the performance of the test.?",
 What should be provided to confirm that final manufacturing of the dev?, additional chemical characterization information
 What is the need for genotoxicity evaluation for combination products that include a biologic?, case-by-case basis
 What is a structure activity relationship modeling technique that is needed in the absence of experimentally derived carcinogenicity information?, SAR
 What is the multifactorial nature of carcinogenesis?, carcinogenesis is multifactorial
 What is the name of the document that would be helpful to a carcinogenicity evaluation?, Attachment B
 What is the TTC approach used for?, to determine if quantification without chemical identifica
 What is needed to address 100 additional questions of safety or effectiveness raised by the proposed use or function of a 101 constituent part in the combination product?, 100 additional questions
 What would be present in an individual worst- case patient exposure situation?, how much of each chemical
 What is the ICH M7 Guideline about?, sensitivity needed
 What is the propensity of the site to develop local tu?, device implant site and propensity of the site to develop local tu
 What is warranted when data are not available to provide an adequate assessment?, carcinogenicity testing
 What is a probable risk?, use of transgenic animal models
" What is the potential effects of medical devices, materials and/or their extracts on reproductive function, embryonic development, and prenatal and early postnatal development?", developmental toxicity
 What is the name of the study that involved the use of chemical neoplasia in laboratory rodents?," 61Huff, J., et al."
 What is a potential for chemical leachables to contact reproductive organs?, novel implant materials
 What does FDA recommend that in vivo degradation assessments be conducted in?, an appropriate animal model
 What is the source of the toxicity of a degrading device?, potential chemicals of concern
 What may raise additional safety and efficacy 110 considerations?, a change in route of 109 administration for a complex biological product
 What risks does testing for toxicological risks pose to the patient?, loss of mechanical properties
 What is the evaluation of safety for devices where the patient-contacting portions may contain potentially toxic chemicals?," chemical risk (i.e., the level of toxicological concern) and the type and duration of exposure"
 What may not necessarily be limited to those endpoints identified by ISO 10993-1 for a specific type and duration of contact?, toxicity assessment
 What is the name of the document that describes the toxicological risks of novel materials?, ISO 10993-1
 What may not be possible to mitigate the toxicological risks with traditional biocompatibility testing?, For some devices including chemicals with known toxicities
 What are some endpoints that may be better assessed through chemical characterization and a review of the literature?," genotoxicity, carcinogenicity, and developmental toxicity"
 What may be necessary to determine the cause of a toxici?, additional chemical characterization and toxicology information
 What is needed to support the risk assessment for devices using materials where a “long history of safe use” rationale would not be sufficient to understand the effect of formulation additives and manufacturing methods and conditions on the biocompatibility of the medical device in its final finished form?,
 What can be used to confirm if there are additional types or quantities of impurities in the new material or component that could impact biocompatibility?, comparative chemical characterization
 What is the name of the biologic licensing agreement?, BLA
 What is an important task for applicants?, Developing a framework that identifies where information gaps may exist in a combination 120 product development program
 What is the CAS number for emical Abstract Services?, CAS
 What would be the name of any other devices marketed?, marketed
 What is the name of the device that is used in the US?, device
 What solvents may be sufficient to support the biocompatibility evaluation of the device?," semi-polar (e.g., isopropyl alcohol, ethyl alcohol, alcohol/water) and non-polar (e.g., hexane) solvents"
 What should be provided to evaluate the patient exposure to the device or device component chemical(s)?, An exposure assessment for each chemical (including any related impurities) to which the patient has direct or indirect contact
 What can be conducted using the chemical characterization testing methods described above for elution?, this testing
 What is the reason for the information above confirms that there are no toxicity concerns for the device or device component chemical?, the chemical is physically sequestered in a device component with no direct or indirect tissue contact
 What should be provided if the information above suggests that there is patient exposure to the device or device component chemical?, toxicological information
 What is needed unless a scientific rationale is provided to explain why these additional tests are not needed?,
 What is needed if extractables and/or leachables data demonstrates exposure will be below the Answer: exposure will be below the Answer: Answer: exposure will be below the Answer: Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the?,
 What is the TTC?, if a TI cannot be derived
 What is the Center for Biologics Evaluation and Research?, Center for Devices and 124 Radiological Health
 What is needed to determine how much of the chemical?, further information
" What should be provided to demonstrate the amount of chemical(s) to which the patient may be exposed (e.g., amount released) through 30 days?",
" What should be provided to demonstrate the amount of chemical(s) to which the patient may be exposed (e.g., through elution)?",
 What is the ADME?," absorption, distribution, metabolism, and excretion"
 What may give users a false sense of security when using a medical device?, Use of such terms may give users a false sense of security
 What does FDA recommend the use of a statement based on?, a material certification
 What does FDA recommend that a sponsor provide to support that the device does not include the material at a level that could result in an adverse event?, data
 What must final labeling comply with before a medical device is introduced into interstate commerce?," 21 CFR Parts 801 and if applicable, 809"
 What is the name of the document that contains Nonbinding Recommendations?, Natural Rubber Latex – Guidance for Industry and Food and Drug Administration Staff
 What is a common endpoint for evaluation of ices?, either additional or fewer endpoints than indicated
 What is the stepwise approach presented below to conduct?, 129 gap analysis
 What is the most informal way to obtain device categorization information?, email
 What is the FDA's guidance document called?, Requests for Feedback and Meetings for Medical Device Submissions: The Q- Submission Program
 What is the duration of contact?, prolonged Category Contact
 What is the Tissue including?, tissue fluids and subcutaneous spaces
" What should be provided for any devices, device components, or materials remaining in contact with tissue that are intended to degrade?", Degradation information
 What is the name of the column in ble A.1 that includes separate columns for subacute and subchronic toxicity endpoints?, ble A.1
 What is not appropriate to use data from an acute systemic toxicity or implantation study in place of a separate pyrogenicity evaluation?, periodic temperature measurements
 What is the name of the attachment that contains nonbinding recommendations?, Attachment B: Device Master Files for Biocompatibility Evaluations
 What is the name of the chemical component that is hemical in the formulation?, chemical component
" What is the name of the zation method that includes a. Identification of material(s); b. Analysi(e)s for heavy metals; c. Sterilization residuals, if relevant (e.g., ethylene oxide); d. Recommended extraction conditions (solvents, temperatures) and an explanation of such conditions based on material chemistry (e.g., solubility, transition temperature); and f. Results from testing of the mater?",
 What does the sponsor of a combination product submit to the [FDA] using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant?, any incremental risks and benefits posed by such combination product
 What is the name of the surface characterization methods recommended for this material?, ISO/TS 10993-19
 What is the name of the standard that specifies the deviations from the standard?, ISO 10993-5
 What is the name of the table in Table C.1?, Table C.1
 What is the name of the document that is used to document the sterilized device?, V2
 What is a known carcinogen?, Material X
 What is the main chart of the FDA's biocompatibility evaluation?, 49 Contains Nonbinding Recommendations Attachment D: Biocompatibility Evaluation Flow Chart
 What should all test reports address?, reporting provisions of any referenced standards
 What should the test report explain if the test uses extracts?, how those extracts were prepared
 What should the test report provide if the method used is not in a published guidance document or FDA-recognized standard?, a complete description of the method
 What is the name of the FDA's Pilot Program for biocompatibility testing of medical devices?, ASCA
 What should the 136 safety and effectiveness profile include for Combination Product B in comparison with Combination Product A?," a clear, comprehensive listing of the 137 differences in the device constituent part, the drug constituent part, and the combination 138 product as a whole"
 What are both compendia and guidance?, ISO 10993 series of standards
 What should be provided for any tests selected under the ISO 10993 paradigm?, the rationale for the test battery selected and the criteria used to determine acceptance
 What should be provided in the test report?, a rationale for the acceptance criteria
 What should the test report include a discussion of?, any test-specific issues that might have affected results
 What should the clinical relevance of the study conclusions be described in?, the test report or in the submission to FDA
 What is the chemical name identical to in the final finished form?, component name
 What is the device identical to?, medical de
 What are some of the chemicals that have not been added to the medical device?," plasticizers, fillers, additives, cleaning agents, mold release agents"
 What should a sponsor include in the submission number and date where the legally marketed device was given marketing authorization?, the submission number and date where the legally marketed device was given marketing authorization
 What can be applied to the medical device in its final finished form?, results from the [name] (legally marketed device)
 What is the name of the CADe device that this guidance applies to?, CADe devices
 What are some changes to the local injection adverse reaction profile?, 141 142
 What could result in a toxic response?, Changes in raw material suppliers or raw material specifications
 What should the sponsor use if there are any formulation changes the sponsor believes will not alter the biocompatibility of the medical device in its final finished form?,
 What should the sponsor use if there are any formulation changes the sponsor believes will not alter the biocompatibility of the medical device in its final finished form?, componen
 What may result in changes to physical properties and/or surface characteristics of resin?,
" What qualifier is included in the FDA submission exhibit [#], page [#], submitted on [date]?",
 What can be applied to the proposed medical device in its final finished form?, results from the test article
 What can be applied to the medical device in its final finished form?, results from the [name] (legally marketed device)
 What may warrant a new risk assessment or new testing if the upper and lower bounds of each component have not been previously evaluated?, Formulation changes that introduce novel components
 What does FDA want to discuss to support their assessment of the medical device?, formulation of the medical device in its final finished form and possible impurities or leachable chemicals
 What is the policy outlined in this Attachment?, a least burdensome76 approach
 What is the approach partially based on?, FDA’s review experience in premarket submissions with these common synthetic polymers and natural fabrics
 What is the 21 CFR 820.70?, Production and process controls for manufacturing
 What is the name of the submission requirements for approval?, safety and effectiveness
 What should manufacturers process complaints in a uniform and timely manner?," cytotoxicity, irritation, or sensitization"
 What is the name of the nonbinding recommendations that must be reported to FDA under 21 CFR 803?,57
 What does FDA recommend that external stakeholders submit to the docket to suggest the addition or removal of?, device materials or exclusion characteristics
 What should FDA include when suggesting the addition of a material?, identification of the FDA medical device product code(s) where the material is commonly used with intact skin
 What should devices included in the policy outlined in this Attachment meet?, all of the following characteristics
 What is the duration of contact for a long term device?, >30 days
 What is the risk that Neonatal skin and the skin of infants with low birthweight is more permeable?, risk
 What may lead to higher “unsafe” levels of toxicants during pregnancy?, Physiological alterations during pregnancy
 What can animal or plant material cause?," cytotoxicity, irritation, or sensitization"
 What is the ABS?, Acrylonitrile-butadiene-styrene plastic
 What can be bridged and leveraged to support approval of Combination Product B?, existing information on Combination Product A 173 can be bridged and leveraged
 What is the name of the nonbinding ingredient that is not used to obtain feedback for combination products?, Polycarbonate
 What is the name of the high density polyethylene?, HDPE
 What is the reason for exclusion Intact skin contacting components There are known risks or we do not have adequate fabricated from materials that are not experience with these materials that may introduce explicitly included in th Policy?, Intact skin contacting components There are known risks or we do not have adequate fabricated from materials that are not experience with these materials that may introduce explicitly included in th Policy: Intact skin contacting components
 What is an increased risk that polymerization or materials?, Fabricated from in-situ polymerizing
 What can introduce a toxicity risk?, The hydrogels manufacturing process
 What can cause adverse biological responses?, Reprocessing of such devices
 What is the only contact with the skin that is used to fabricate the device or component?, direct or indirect skin contact
 What is the name of the section that the FDA recommends that a study be done?, Section D(1)above
 What does FDA recommend that study sponsors describe in IDE progress reports?, any adverse biological responses from devices within this intact skin policy
 What is not necessary to include in a premarket submission?, detailed rationale regarding manufacturing
 What can be reviewed and used to address these gaps under the proposed regulatory pathway as 179 described in Step 5 below?, Not for Implementation 178
 What has been identified through biocompatibility testing?," cytotoxicity, irritation, and sensitization"
 What is FDA’s Recommended Co?, What is FDA’s Recommended Co
 What is the format and content recommendation for certain labeling information related to this policy?, This section contains FDA’s format and content recommendations
 What should caretakers assess patients for on the skin where?, adverse reactions
 What is the term used for a device or device component that comes into physical contact with body tissue?, Indirect contact
 What is the term used for a device or device component that has no direct or indirect contact with the body?, Non-contact
 What is the name of the book that describes the fundamentals of biocompatibility?, Biological Performance of Materials: Fundamentals of Biocompatibility
 What is the risk of a chemical substance or material causing injury or death?," capable of causing injury or death, especially by chemical means"
 What is the name of the dictionary that describes the Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process?,
 What may be challenging or not possible with some combination products 191 because they contain complex constituent parts and/or are likely to be affected by seemingly 192 minor changes.?,
 What is the part of the risk management process that involves the evaluation and testing of medical devices?, Evaluation and testing
 Who is the Office of Health Technology 8?, Office of Radiological Health
 What is the address of the Dockets Management Staff of the Food and Drug Administration?," 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852"
 What does not establish any rights for any person and is not binding on FDA or the public?, guidance
 What is the IEC's standard 60825-1: Safety of laser products?, 60825-1: Safety of laser products
 What is the edition of IEC 60601-2-22 Ed. 2-22?, Medical electrical equipment
" What does FDA's guidance documents, including this guidance, do not establish?", legally enforceable responsibilities
 What does Laser product mean?," any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system"
 What are the two definitions of a medical device and an electronic product?, 201(h) and 531(2)
 What did CDRH previously issue notices to?, laser product manufacturers and importers
 What are the framework and associated analyses in this guidance potentially 196 applicable to?, such combination products
 What does IEC stand for?, International Electrotechnical Commission
 What may cause manufacturers to duplicate their efforts?, Complying with FDA regulations and conforming to the identified IEC standards
 What does FDA acknowledge the advantages of?, one set of criteria and requirements worldwide
 What is the chapter on Radiological Health in 21 CFR?, Subchapter J
 What is the name of the guidance issued by FDA?, Laser Notice No. 56
 What does FDA not intend to enforce if the laser product conforms to IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1?, applicable FDA requirements
 What is the name of the IEC standard?, IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
 What is the equivalent clause to?, 1040.10(b) Definitions 1040.10(c)(1) Classification* 1040.10(d) Accessible emission limits 1040.10(e) Tests for determination of compliance 1040.10(f)(1) Protective housing
 What is the name of the document that specifies the interpretation sheets for laser products?, IEC-60601-2-22-laser-notice-no-50 3 Contains Nonbinding Recommendations 1040.10(f)(2) Safety interlocks** 1040.10(f)(3) Remote Interlock connector 1040.10(f)(4) Key control 1040.10(f)(5) Laser radiation emission indicator 1040.10(f)(6) Beam attenuator 1040.10(f)(7) Location of controls 1040.10(f)(8) Scanning safeguard 1040.11(a) Medical laser products *
 What may FDA request from your product Classification Testing to confirm that the laser product is properly classified?,
 What indirectly requires redundancy or safe-failure for safety interlocks designed to protect against human?, IEC 60825-1 Ed. 3 (6.3)
 What are the cases represented by?, hypothetical examples
 What is the reasonably foreseeable single-fault condition sub-clause?, Classification Rules (4.3)
 What may laser product manufacturers find useful for inclusion in correspondence and applications for variance or exemption?, this information
 What are not comparable to FDA’s performance standards under 21 CFR 1040.10 and 1040.11?, IEC clauses and annexes
 What does Sub-clause 3.25 (definition of collateral radiation) of IEC 60825-1 Ed. 3 not include?," all electromagnetic radiation (e.g., X-ray emissions) found in the FDA definition at 21 CFR 1040.10(b)(12)"
 What is not comparable to FDA’s performance standards?, Sub-clause 3.49 (definition of laser radiation) of IEC 60825-1 Ed. 3
 What is the FDA definition of collateral radiation?, 21 CFR 1040.10(b)(22)
 What is the FDA's requirement that collateral radiation be measured separately when making classification measurements?, 21 CFR 1040.10(c)
 What does Clause 6.1 contain that manufacturers may find helpful?, ensuring that personnel responsible for classification receive training
 What is the FDA performance standards for laser products not comparable to?, 21 CFR 1040.10
 What is mandatory in 21 CFR 1040.10(d)?, assessments of collateral radiation
 What is the sub-clause 9.4 of the guidance on electric toys?," Sub-clause 9.4 Electric toys of IEC 60825-1 Ed. 3: For guidance on “electric toys,” please see FDA’s guidance entitled “Minimizing Risk for Children’s Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff.”6 B. Performance Standards Not Subject to this Guidance"
 What are these FDA performance standards included as recommendations in?, User’s Guide clause of the IEC standards
 What must the certification be provided on?, a label or tag permanently affixed to or inscribed on the product
 What does Laser Notice No. 56 describe?, Conforms with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
 What should be documented and placed in the firm's records?, Testing results
" What is the name of the document that contains Nonbinding Recommendations Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff Document issued on February 21, 2023?",
 What is the docket number of FDA-2016-D-2049?, FDA-2016-D-2049
 What is the purpose of the EPRC Regulations?, Avoidance of Duplication
 What is the name of the Clearance for Medical Devices?, 510(k)
 What does FDA encourage the applicant to conduct?, clinical studies
 What does the guidance not establish any rights for?, any person
 What is the FD&C Act?," Federal Food, Drug & Cosmetic Act"
 What must manufacturers and importers of medical x-ray imaging equipment follow?, current EPRC regulations and pr
 What does FDA's guidance documents describe?, Agency's current thinking on a topic
 What is the definition of an electronic product under the FD&C Act?, 531(2)
 What is the FDA is issuing this guidance to clarify?, relevant applicable standards
 What is the second aspect of FDA categorizing medical devices?, Compliance with EPRC performance standards
 What is the name of the section that regulates misbranding?,502
 What is the general provisions of the FD&C Act?, general provisions
 What is the minimum amount of a 510(k) submission required for Class I devices to be legally marketed?, o 21 CFR 820
 What is the term for egulatory pathways?, egulatory pathways
 What must manufacturers receive FDA approval of before marketing?, a premarket approval application
 What must manufacturers and importers comply with?, applicable requirements
 What is the 21 CFR Part 1004?," Repurchase, repairs, or replacement of electronic products"
 What is the name of the equipment that is used in the manufacture of microwave ovens?, Microwave ovens
 What are the regulations and product codes for these devices in Tables 1 and 2?, Regulations and product codes
 What is the name of the class of devices that are covered by thi?, Class II devices
 What is the name of the radiographic film/cassette changer?, KPX
 What is the name of the 510(k) process?, cleared for market
 What does this guidance clarify?, relevant applicable voluntary consensus standards for medical x-ray systems and components
 What is the part of IEC 60601-2-63 that contains Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment?, Part 2-63
 What is the name of the document that describes the reclassification of Medical Image Analyzers?, “Radiology Devices; Reclassification of Medical Image Analyzers”
 What is the initial plan to market the NME in?, prefilled 224 syringe
 What is the minimum level of protection from electronic radiation that a manufacturer would have from IEC standards?, same level
 What is the name of the transition period that is associated with the recognition of newer versions of consensus standards?, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
 What is the minimum level of protection from electronic product radiation?, conformance to the identified IEC standards
 What is the EPRC requirement deemed to have met based on conformity to applicable IEC standard(s)?, EPRC requirements deemed to be met based on conformity to applicable IEC standard(s)
 What is the name of the section that the FDA has determined is not adequately addressed?, section 3b
 What is the section of the FD&C Act that is not deemed to have met the requirements?, Section 514(c)(1)(B)
 What do IEC standards 60601-2-63 and 60601-2-65 use to determine whether the device is an extra-oral device or an intra-oral device?, location of the image receptor
 What must manufacturers establish to obtain 510(k) clearance?, substantia
 What section of the FD&C Act supports a substantial equivalence?, 513(i)
 What is the route of administration of the drug?, subcutaneous
 What must manufacturers and importers include a declaration of conformity as part of?, a premarket submission
 What is the guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”?," Information on such declarations is available in the guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”18 VI. Certification Manufacturers of diagnostic x-ray systems, and their major components, for which an applicable EPRC performance standard is in effect, including those that conform to applicable IEC standards to meet EPRC performance standards, must provide certifications for their products."
 What must the certification be provided on?, a label or tag permanently affixed to or inscribed on a product
 What is the FDA Recognized Standards Database available at?, https://www.fda.gov/regulatory-informati
 What does a CT device comply with?, 21 CFR 1020.30
 What is the 21 CFR 1010.2(c)?," this certification must be “based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing pract”."
 What should be documented and placed in the firm’s records?, Testing results
 What does section 1020.30(g) help to ensure?, diagnostic x-ray equipment
 What should a manufacturer include in their AIAT documentation?, Radiation Safety Specification and Testing Comparison Document
 What does the autoinjector change about the method of injecting the drug constituent part?, 238 injecting the drug constituent part
 What is the purpose of the FDA's recommendation for manufacturers to format their AIAT documentation?," so that all radiation safety specifications and test methods, including acceptance and constancy testing, are available in a format that Answer: FDA recommends that manufacturers format their AIAT documentation so that all radiation safety specifications and test methods, including acceptance and constancy testing, are available in a format that Answer: FDA recommends that manufacturers format their AIAT documentation"
 What should the document include if the device does not otherwise meet EPRC performance standards?, radiation safety specifications
 What is the name of the document that is being replaced by the IEC standard?, IEC standard
 What is a manufacturer using a declaration of conformity to comply with certain requirements?, a declaration of conformity
 What must a manufacturer's quality system address?, various aspects of radiation safety and conformity to standards
 What does FDA find a manufacturer’s testing program does not assure the adequacy of safeguards against?, hazardous electronic product radiation
 What is the FDA's guidance available at https://www.fda.gov/regulatory?, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
 What is the purpose of testing that supports a declaration of conformity?, for more information about testing that supports a declaration of conformity
 What must manufacturers and importers do when they discover a radiation safety defect?, notify FDA
 What is the base standard of the IEC?, general standard
 What may change the safety and effectiveness profile of the user interface?, The difference in the user interface design
" What may replace, add to, amend, or remove conditions contained in the general or collateral standards?", Particular standards apply to specific types of equipment
 What is conformance to a particular standard included in?, conformance to any collateral standards and the general standard in the same series
 What does the far-left column list?, the classificat
 What does the column marked with an ‘X’ provide?, the names of the IEC standards that apply to that device
 What is the name of the equipment that is used in mammography?, KPX
 What do IEC standards 60601-2-63 and 60601-2-65 use to determine whether the device is an extra-oral device or an intra- oral device?, the location of the image receptor
 What is the applicable standard for all other devices under 21 CFR 892.1650?, IEC 60601-2-54
" What is the name of the Nonbinding Recommendations Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring Guidance for Industry and Food and Drug Administration Staff Document issued on October 19, 2023.?",
 When was the COVID-19 Public Health Emergency issued?, March 2020
 What is the CMC?," chemistry, manufacturing, and controls"
 What is the docket number of FDA-2023-D-4356?, FDA-2023-D-4356
 What is the document number for the guidance?, GUI00020014
 What does the guidance not establish any rights for?, any person
 What is the FDA's role in protecting the United States from?, emerging infectious diseases
 What was the purpose of this guidance?, to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to address the PHE
 How long does the guidance document continue in effect after the COVID-19 PHE declaration expire?, 180 days
 What is the name of the guidance document that is intended to facilitate patient monitoring while reducing patient and healthcare provider?, COVID-19
 When did the Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring expire?," May 11, 2023)"
 What has FDA evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies?, exercised certain enforcement policies
 What do we recommend you include if submitting a Declaration of Conformity to a recognized standard?, appropriate supporting documentation
 What is the autoinjector designed to meet a specific injection time specification?, autoinjector
 What has FDA determined about the use of consensus standards in regulatory submissions?, prior public participation for this guidance is not feasible or appropriate
 What is the guidance document being implemented immediately?, this guidance document
 Where can you find the Agency guidance?, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
 What does the inal device measure?, common physiological parameters
 What is the name of the pressure measurement system used in the CFR?, Noninvasive blood
 What is the name of the section of the FD&C Act that exempts devices with the product codes listed in Table 1?, 510(k)
 What are the two types of stethoscopes covered by this classification regulation?, manual and electronic
 What is the name of the 510(k) exempt system that PKQ II cognitive assessment is exempt from?, PTY II
 What is not exempt from 510(k) of the FD&C Act?, otoacoustic emission devices
 What is the time of injection that determines the rate of drug delivery?, 266 injection time
 What does FDA believe may trigger the requirement that a manufacturer submit a premarket notification?, modifications to existing otoscopes to allow for increased remote monitoring capability
 What is exempt from premarket notification requirements?, computerized cognitive assessment aid
 What is the requirement for marketing new devices within this device type Until the unclassified device type has been classified through regulation?,
 What is the name of the non-invasive monitoring device that can be connected to a wireless network to transmit a patient’s measurements directly to their healthcare provider?, The Oximeter
 What is the name of the non-invasive remote monitoring device that was removed from Table 1 compared to previous versions of FDA’s guidance?, Clinical electronic thermometer
 What does FDA not intend to object to?," limited modifications to the indications, functionality, or hardware or software of certain non-invasive remote monitoring devices"
 What is a premarket notification called?, 510(k)
 What is CDRH's 2022-2025 strategic priorities?, focusing on advancing health equity
" What can advance better care, quality of life, and wellness of diverse populations?", digital health technologies
" What may require premarket notification if modifications to the indications, functionality, or hardware or software of 510(k)-exempt devices in Table 1 may require?",
 What is the policy supporting?, this strategic priority
 What did the applicant conduct with the PFS presentation?, phase 3 studies
 What does the enforcement policy in this guidance address?, premarket notification
 What would not be within the scope of th FDA?, modifications to the indications or functionality that could create such undue risk or that could affect the physiological parameter measurement algorithm
 What would not be within the scope of this policy?, modifications to add new indications or device software functions
 What is a distinct purpose of the product?, function
 What is a “device software function”?, a software function that meets the definition of a device under section 201(h) of the FD&C Act
 What is the 21 CFR 801.5?, describes a number of reasons why directions for use may be inadequate
 What is the purpose of the information on the device?, Information on use conditions
 What should the manufacturer consider in Section III.A?, hardware or softwar
 What is a common reason for device hardware or software architecture modifications?, may warrant accompanying non-device22 and device hardware or software architecture modifications
 What does not affect the physiological parameter measurement algorithm?, such a change would generally be within the scope of this policy
 What do constituent parts of a combination product retain after they are combined?, regulatory status
 What is the Collateral Standard for Electromagnetic Disturbances?, Electromagnetic Disturbances
 What is the FDA's guidance on Medical Image Communications Devices?, Medical Image Communications Devices
 What is the Collateral Standard for?, Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
 What is the AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers?, AIM 7351731
 What is the part 5-1 of IEC 81001-5-1 for?, Security
 What is effective cybersecurity necessary to ensure?, the safety and functionality of such devices
 What is the CGMP requirement of the QS regulation?, good manufacturing practice
 What did FDA want to incorporate by reference?, 2016 edition of the International Organization for Standardization (ISO) 13485
 What is the name of the part of the proposed rule that specifies the requirements for quality management systems for Medical devices?, part 820
 What is the FDA's role in Medical Device Cybersecurity?, The FDA’s Role in Medical Device Cybersecurity
 What may manufacturers meet under a streamlined approach?, drug CGMPs and device quality system QS regulation
" What is the name of the document that the FDA issued on July 1, 2020?", Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
 What is the name of the U.S. Department of Health and Human Services Center for Devices and Radiological Health Center for Biologics Evaluation and Research?, OCOD
 What is the name of the office that FDA is in charge of approving comments to the document?," 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852"
 What is the OCOD?," Office of Communication, Outreach, and Development"
 What is the Policy Answer: Compliance Policy for GUDID Submission Requirements for Class I Devices?,
" What are the Class III, LS/LS, and Class II Non-Sterile Devices Manufactured and Labeled Prior to the Established Direct Mark Compliance Date That Remain in Inventory?"," Class III, LS/LS, and Class II Non-Sterile Devices"
 What does the guidance not establish any rights for?, any person
 What is FDA's unique device identification system designed to adequately identify?, devices through distribution and use
" What is Section 519(f) of the Federal Food, Drug, and Cosmetic Act?", UDI system regulations
 What can a labeler of a class I device determine?, whether its device is within the scope of that compliance policy
 What is the classification of CADe devices?, 21 CFR 892.2050
 What is the procurement controls of the CGMP?, 21 CFR 820.50
" What do the terms ""you"" and ""your"" refer to in this guidance document?", the labeler
 What is the FDA determined is a less burdensome policy that is consistent with public health?, this approach
 What is the guidance subject to comment in accordance with?, the Agency’s good guidance practices
 What should be viewed as recommendations?, FDA guidance documents
" What is the name of the rule that the FDA published on September 24, 2013?", UDI system
 What is the range of compliance dates for the UDI Rule?," September 24, 2014, to September 24, 2020"
 What is the UDI Rule also required that data pertaining to the key characteristics of each device required to bear a UDI be submitted to?, FDA’s GUDID
 What did FDA align the compliance date for standard date format requirements with?, compliance date by which a device must bear a UDI on its label and packages
 What does the UDI system seek to improve?, the identification of medical devices
 What is the UDI policy regarding?, Compliance Dates for Class I and Unclassified Devices
 What is the focus of design control discussion in this guidance?, the information required to demonstrate that the final combination product achieves its identified performance
 What did the prior versions of this guidance reflect?, our belief that it was important to continue focusing our resources on addressing UDI implementation issues and data quality for higher risk devices
 What is the lowest risk of UDI devices?, class I devices
 What is the UPC used for?, a barcode
 What is the public benefit of GUDID submission for consumer health products?, public health benefit
 What does FDA not intend to enforce for consumer health products?, GUDID submission requirements
 What was the prior version of the guidance that FDA did not intend to enforce?, direct mark requirements
 What is the UDI Rule for class I devices?, the UDI Rule
 What are typically used in healthcare settings and are often subject to additional regulatory controls?, These devices are typically used in healthcare settings
 What is the purpose of the submission of UDI data into GUDID?, to evaluate and improve device safety throughout the product lifecycle
 What did FDA say in the 2020 UDI Compliance Policy Guidance?," we did not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than I/LS/LS devices"
 What are some of the data needed to make such design verification and validation demonstrations?," bench data, preclinical/clinical testing data, and human factors (HF) studies"
 What does 21 CFR 830.300 require for class I and unclassified devices?, GUDID submission requirements
 What is the name of the device that is manufactured and labeled before the labeler has implemented direct marking?, finished devices
 What can entail different design changes and design validations than those made in order to add a required UDI direct mark to future lots of the device?, remediating existing devices in inventory
" What may be used to facilitate recalls and medical device reporting, in analysis of premarket approval application (PMA) annual reports, and for other FDA processes?", GUDID data
 What is the tail of the 85 FR 39477?, tail
 What is the compliance date for class I and unclassified devices?, 21 CFR 801.20
 What is the compliance date for Finished class I and unclassified devices?," September 24, 2018"
 What is the Compliance Policy for GUDID Submission Requirements for Class I Devices 1?, Compliance Policy for GUDID Submission Requirements for Class I Devices 1. Class I Devices Considered Consumer Health Products
 What does “consumer health products” mean?, 510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores and that do not fall within one or more of the categories
 What is the policy for 2020 UDI Compliance Policy Guidance?, 85 FR 39477
 What is a biological product regulated under section 351 of the Public Health Service Act?, a drug or a device
 What is the name of the agency that determines that class I devices are not considered consumer health products?, FDA
 What are er risk devices subject to?, additional regulatory controls
 What is the majority of class I devices exempt from?, the 510(k) premarket notification process
 What is a clinical labora?, a clinical labora
 What is the name of the subpart B of 21 CFR 801.40?, 21 CFR 801.40
 What is the name of the UDI that a user can use in addition to a UPC?, UDI
 What is the definition of a prescription use?, prescription use
 What is a life-supporting or life-sustaining device defined at 21 CFR 860.3 as?," a device that is “essential to, or that yie Answer: Life-supporting or life-sustaining device”"
 What does FDA recommend evaluating to determine if a particular device is life-supporting or life-sustaining?, the device’s intended use
 What is the purpose of reusable vices?, intended for use by healthcare professionals only
" What is the PFS for the PFS, elastomeric plunger, and needle?", the PFS
 What is the term for a device that is intended to be used more than once on or by the same patient?, reusable
 What does an unclassified device generally require?, submission of a 510(k) premarket notification
 How many calendar days are required to submit a GUDID submission under 21 CFR 830.300 for unclassified devices?, 75 calendar days
 What is the direct mark compliance date for LS/LS devices?," September 24, 2015"
 What is the purpose of this provision?, reduce burden associated with the UDI Rule for inventories of finished devices that were manufactured and labeled prior to the applicable compliance date
 What is the name of the guidance that describes the intention to exempt certain Unclassified Medical Devices from Premarket Notification Requirements?, “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements”
 What does the UDI Compliance Policy Guidance state that we do not intend to enforce the GUDID data submission requirements for?, unclassified devices
 What is the name of the document that may be applicable to UDI?, tem/udi-exceptions-alternatives- and-time-extensions
 What do labelers use the new field(s) to document when the field becomes available?, that their devices are subject to such a method
 What is the ompliance date for class I and unclassified devices?," September 24, 2020"
 What is the step of the applicant that considers whether other existing information may be leveraged to 295 support the items in Step 4?, Step 4
 What is the ark requirements under 21 CFR 801.45 for?, finished class I and unclassified devices
 What is FDA looking for in a method for constructing the UDI?, documented or referenced that method in the DMR
" What is the policy for UDI direct mark requirements under 21 CFR 801.45 for class I and unclassified devices, other than LS/LS devices, remains the same as the policy in the 2020 UDI Compliance Policy Guidance.?",
 What is the name of the FDA's Office of the Commissioner?, Office of the Commissioner
" What is the name of the office of Communication, Education, and Radiation Programs Division of Small Manufacturers, International, and Consumer Assistance Center for Devices and Radiological Health?"," Office of Communication, Education, and Radiation Programs"
 What is the name of the veterinary clinic in the US?, HFV-12
 What is the name of the system that stores data?, Retrieving Data 6
 What does not create or confer any rights for or on any person and does not operate to bind FDA or the public.?,
 What is the name of the FDA staff that implements this guidance?, FDA staff
 What is the applicant considering establishing between the previously approved 302 product and the proposed autoinjector?, a bridge
 What is the source data needed for?," the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs,3 and medical devices"
 What is the name of the guidance that was issued in April 1999?, Electronic Records; Electronic Signatures — Scope and Application
 What does the Agency intend to do with part 11?," interpret the scope of part 11 narrowly and to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying"
 What does the word should mean in Agency guidances?," something is suggested or recommended, but not required"
 What must be the same fundamental elements of data quality as paper records?," attributable, legible, contemporaneous, original,5 and accurate"
 What did FDA say was acceptable under certain circumstances?," electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper"
 What was the final draft guidance for industry entitled?, Computerized Systems Used in Clinical Trials
 What is allowing original documents to be replaced by copies?, copies
 What does this guidance apply to computerized systems that capture analytical results of tests conducted during a clinical trial?, 21 CFR 312.62(b) and 812.140(b)
 What is an example of a computerized system that can be used to record an ECG reading?, an ECG reading
 What is the purpose of the HF validation study?, it will be challenging to bridge the applications
 What is IDE?, Investigational Device Exemption
 What should the computerized systems do?," (1) to prevent errors in data creation, modification, maintenance, archiving, retrieval, or transmission"
 What should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records?, SOPs
 What is the source document when original observations are entered directly into a computerized system?, the electronic record
 What is the name of the system that a data is entered directly into a remote computerized system?, a remote computerized system
 What must be limited to authorized individuals?, Limited Access Access
 What should individuals work only under?, their own password or other access key and not share these with others
 What should someone do when they leave a workstation?, log off the system
 What does the use of audit trails help to ensure?," only authorized additions, deletions, or alterations of information in the electronic record have occurred"
 What should be determined based on a justified and documented risk assessment?, The need for audit trails
 What did the applicant believe it could leverage because of the previously approved autoinjector design?, design verification data unrelated to the drug being injected
" What should describe when, by whom, and the reason changes were made to electronic record activities?", Audit trails or other security methods
 Who should be notified if a system date or time discrepancy is detected?, authorized personnel
 What do systems recommend that dates and times include?," year, month, day, hour, and minute"
 What is better for systems that span different time zones?, time stamps
" What should be put in place to prevent the altering, browsing, querying, or reporting of data via external software applications that do not enter through the protective system software.?",
 What should be kept in the study documentation?, that record
 What can be used to permit repopulation of information specific to the subject?, programming features
 What should be designed in a way that retrieved data regarding each individual subject in a study is attributable to that subject?, computerized system
 What is not necessary to reprocess data from a study that can be fully reconstructed from available documentation?," actual application software, operating systems, and software development tools"
 What should be designed to protect against data loss?, sufficient backup and recovery procedures
 What is the applicant planning to provide design validation confirming?, that the autoinjector 323 performance specifications are adequate
 Where should records be stored?, at a secure location
 What should be documented for changes that exceed previously established operational limits or design specifications?, Changes that exceed previously established operational limits or design specifications
 What should be provided to individuals in the specific operations with regard to computerized systems that they are to perform?, Training
" What is a process that captures details such as additions, deletions, or alterations of information in an electronic record?", Audit Trail
 What is an example of a computerized system?, user manual
 What is an electronic record?," any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained"
 What is allowing original documents and the original data recorded on those documents to be replaced by copies?, copies
 What is the purpose of a Transmit?," to transfer data within or Answer: Answer: at the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical trial"
 What is the name of the guideline for the Monitoring of Clinical Investigations?, Guideline for the Monitoring of Clinical Investigations
 What should the SOPs include?, System setup/installation
 What is the OEB?," lung computed tomography system, computer-aided detection"
 What is the name of the document that contains nonbinding recommendations Draft—Not for Implementation?, 21 CFR 820.30(g) & (j)
 What is the name of the system maintenance?, System decommissioning
 What is the name of the agency that oversees the use of computerized systems in clinical trials?, Office of the Commissioner
 What is the phone number for the Drug Information Center for Drug Evaluation and Research?, 301-827-4573
 What is the name of the veterinary center that is located in the US?, HFV-12 Center for Veterinary Medicine
 What is the name of the office that oversees the Food and Drug Administration?, Office of the Commissioner
 What does the guidance represent?, the Food and Drug Administration's (FDA's) current thinking on this topic
 What is the FDA's staff responsible for implementing?, this guidance
 What are CROs?, data management centers
 What is the name of the guidance dated April 1999?, Part 11
 What is the purpose of the local adverse event data?, assess how the new interface may affect pain on delivery
 What is the ICH E6 Good Clinical Practice consol?, Answer: Answer: ICH E6 Good Clinical Practice consol
 What are the terms used in FDA guidance to describe the same information?, source documents
 What does ICH stand for?, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
 What is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject?, computerized systems
 What is the requirement for FDA's acceptance of data from clinical trials for decision-making purposes?, FDA's ability to verify the quality and integrity of the data during FDA on-site inspections and audits
 What did FDA and industry want to do with part 11?," proposeing additional rulemaking, and exercising enforcement discretion regarding enforcement of certain part 11 requirements"
 What is the final version of the draft guidance for industry entitled Electronic Records; Electronic Signatures – Scope and Application (Scope and Application Guidance) dated August 2003.?,
 What is the approach outlined in the Scope and Application Guidance?, The approach outlined in the Scope and Application Guidance
 What should be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application?, principles outlined in this guidance
 What is an example of a recorded source data transmitted from automated instruments directly to a computerized system?, chemistry autoanalyser
 What is the purpose of the company's testing related to sterility and degradation?, g. Note that the company’s testing related to sterility and 337 degradation would primarily be intended to verify that the new process did not create 338 issues. the company’s testing related to sterility and 337 degradation
 What does the guidance not apply to?, computerized medical devices that generate such data and that are otherwise regulated by FDA
 What is IDE?, Notice of Claimed Investigational Exemption for a New Animal Drug
" What is an example of a standard operating procedure that should be in place when using computerized systems to create, modify, maintain, or transmit electronic records?", inadvertently unblinding a study
 What should be made available for use by personnel and for inspection by FDA?, SOPs
 What is the requirement for source document retention?," retention of the original source document, or a copy of the source document"
 What should be maintained at another location?, a copy of the data
 What should the system be designed to limit?, the number of log-in attempts
 What should be changed at established intervals commensurate with a documented risk assessment?, passwords or other access keys
 What is an example of a security measure that can prevent data entry until a password is entered?, an automatic screen saver
 What can be used to verify the quality and integrity of data?," Computer-generated, time-stamped audit trails or other security measures"
" What is the tissue 349 plane in which the drug is delivered, changes to the rate of delivery, and changes in the 351 consistency of the combination product?"," Changes in delivery include changes in the tissue 349 plane in which the drug is delivered, changes to the rate of delivery (because of 350 change in injection time between the PFS and autoinjector), and changes in the 351 consistency of the PK 348 profile"
 What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  What is the pref  Who should not be able to modify the documents or security measures used to track electronic record changes?," personnel who create, modify, or delete electronic records"
" What should describe when, by whom, and the reason changes were made to the electronic record?", Audit trails
 What should be notified if a system date or time discrepancy is detected?, authorized personnel
 What is the most likely use of computerized systems?, multi-center clinical trials
 What should be put in place to ensure that access to the computerized system and to the data is restricted to authorized personnel?, external safeguards
" What should be kept in the study documentation, accessible for use by appropriate study personnel and for inspection by FDA investigators?", That record should be kept in the study documentation
 What is the main effect of computer viruses and worms on study data and software?, harmful software code
 What should you do to avoid falsification of data?, perform a careful analysis
 What should FDA describe and explain how source data were obtained and managed?, how electronic records were used to capture data
 What should be retained as part of the study records and be available for inspection by FDA?, this documentation
 What will the extent to which existing safety data or 352 effectiveness data can be bridged and leveraged depend on?, PK comparisons
 What should be regularly backed up in a procedure that would prevent a catastrophic loss and ensure the quality and integrity of the data?, a procedure
 What should be evaluated and some should be validated depending on risk?, Changes that exceed previously establishes
 What should be documented?, all changes to the system
 What should be documented for the purpose of this guidance?," computer education, training, and experience"
" What is a process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record.?",
 What is a computerized system used for?," create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial"
 What are the values that represent the first recording of study data?, original data
 What are some of the sources of original records?," hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists"
 What is the purpose of a Transmit?," to transfer data within or among clinical study sites, contract research organizations, data management centers, sponsors, or to FDA"
 What is the FDA's Compliance Program Guidance Manual?, Compliance Program 7348.811 - Bioresearch Monitoring - Clinical Investigators
 What is the design verification ensur?, Design validation ensur
 What is the FDA's Part 11 of Electronic Records?, Electronic Records; Electronic Signatures — Scope and Application
" What should the SOPs include, but are not limited to, the following processes?", The SOPs
" What is the Guidance for the Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation?"," Guidance for the Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation"
 What is the branch of Reproductive Abdominal and Radiological Devices that handles Renal Devices?," Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Reso Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: FDA Reviewers Document issued on January 16, 2001 U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Gastroenterology and Renal Devices Branch Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any"
 What is the name of the room in the Food and Drug Administration's guidance document?, Room 1061
 What is the name of the telephone number that CDRH uses to send documents via fax?, 301-827-0111
 What is the pound sign for the nt number 1164?, pound
 What is the Code of Federal Regulations?, Code of Federal Regulations
 What is the name of the FDA's guidance document regarding IDEs?, Investorigational Device Exemptions Manual
 What does this document not address?, preservation of the cornea
" What is the name of the guidance for industry and FDA staff Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products?"," Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products"
 What do we believe need to be addressed before your device can be approved for marketing?, issues identified in this guidance document
 What is the least burdensome approach to resolving the issues presented in the guidance document?, we believe that we have considered the least burdensome approach
 What is the FDA's recommendation for all IDEs for these products?, contain the information described on the following pages
 What should be provided to demonstrate that the chemicals possess sufficient purity for use in this product?, adequate justification
 What should be provided in lieu of biocompatibility testing?, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing
 What should be assessed after storage for specified time periods?, sterility (bacteria and endotoxin)
" What will normally be necessary to demonstrate the safety of the solution and, possibly, to establish the appropriateness of surrogate endpoints that may be used in the clinical trial.?",
 What is the most important factor in selecting the animal model?, relevance to the ultimate clinical use of the product
 What should the control be widely used for?, preservation of the organ in question
 What do foreign sites not require?, IDE approval
 What is the purpose of the concentration-time profile?, applicant intends to gather additional 359 information to evaluate clinical effect of these differences
 What should be provided along with copies of all published or unpublished adverse information?, copies of all published or unpublished adverse information
 What is the control solution currently in use at the investigational site?, heterogeneous control
 What is the FDA's opinion on the use of trol?, The FDA believes that it would be appropriate to include data from at least one U.S. investigational site in the marketing application
 How many sites should the study include?, 4 at least three
 What should be provided to the patient for removal from the study?, A complete listing of the inclusion/exclusion criteria
 What is the primary endpoint of the study?, 7 day graft survival
 What are appropriate secondary endpoints for heart preservation solutions?," cardiac index, wedge pressure, need for inotropic drugs, biopsy results and time in ICU"
 What should be provided to FDA to discuss the issues of “extended” preservation time?, preservation times
 What is the name of the Guidance for Clinical Trials of Non-Diagnostic Medical Devices?,
 What is the name of the Guidance for Industry and Food and Drug Administration Staff Addition of URLs to Electronic Product Labeling Document issued on: September 30 Guidance for Industry and Food and Drug Administration Staff?,
 What is the name of the branch of the Agency that provides electronic products?, Electronic Products Branch
 What did the applicant not intend to modify?, device performance specifications
 What is the address of the Division of Dockets Management?," 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852"
 What is the document number for guidance for Industry and Food and Drug Administration Staff?,1703
 What is the FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA?,
 What does 21 CFR 1010.3(a)(1) and (2) require manufacturers to include on their electronic product labels?," full name and address and place, month and year of manufacture"
 What does FDA's guidance documents do not establish?, legally enforceable responsibilities
 What is the month and year of manufacture on a product's identification tag or label?, 21 CFR 1010.3(a)(1) and (2)
" What does CDRH not recommend in instances where a manufacturer is unable to place its URL, in addition to the required full name and address and place, month and year of manufacture, on its current product label?", inclusion of the URL
 What should a manufacturer point directly to when adding its URL to a product tag or label?, 1. A web page where the manufacturer’s full name and current physical address are posted
 What is one factor the Agency may consider in making such a determination?, The presence of the URL on the product label
 What is the name of the organization that is responsible for the administration of the Ultrasound Stimulator System?, Food and Drug Administration Center for Devices and Radiological Health
 What is the same in the route of administration?, the 374 same (subcutaneous)
 What is the address of the Dockets Management Branch?," 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852"
 What is the name of the document that you are requesting?,1701
 What is the name of the testing method used to determine the device's scope?, Scope
 What is the acronym for Electrical and Mechanical Safety Performance Testing?, EMC
 What is the name of the device that is used for aesthetic use?, Focused Ultrasound Stimulator System
 What is the purpose of the focused ultrasound stimulator system?, for aesthetic use
 What must a manufacturer who intends to market a device of this generic type conform to?," general controls of the Federal Food, Drug & Answer: (1) conform to the general controls of the Federal Food, Drug & Answer: evice"
 What is the FD&C Act?, 21 CFR 807 Subpart E
" What does the FDA identify and describe measures that if followed by manufacturers and combined with the Class II Special Controls Guidance Document general controls, will generally address the risks associated with focused ultrasound stimulator systems and lead to a timely 510(k) review?",
 What is a Focused Ultrasound Stimulator System for Aesthetic Use Identification?, a device using focused ultrasound to produce
 What is the combination or bundle of multiple parallel detection schemes designed to detect?, one type of potential abnormality revealed in the patient radiological data
 What was not changed by the modification of the autoinjector?, the user interface
 What is the purpose of focused Ultrasound Stimulator System for Aesthetic Use?, Focused Ultrasound Stimulator System for Aesthetic Use
 What do we recommend you identify within the scope of the 510(k)?, Device Components
 What is the FDA's general view of evice and the predicate?, indications for use and technological characteristics
 What should you do before submitting your premarket notification to identify other risks?, conduct a risk analysis
 What should be demonstrated that the focused ultrasound stimulator system meets all design specification and performance requirements?, meets all design specification and performance requirements
" What should be demonstrated by measurements of temperature distributions in vitro, such as in tissue mimicking materials, and via computational modeling of the thermal dose?", predictable thermal lesions
 What should be addressed in testing to avoid cavitation and bubble formation?, possible cavitation and bubble formation either in the focal region or at the device-tissue interface
 What should the overall system be tested to ensure proper performance to?, design specifications
 What is the manufacturing process for 392 Prototype 2 comparable to?, that for Prototype 1
 What is the level of concern related to risks associated with?, software failure
 What is the purpose of the focused ultrasound stimulator system?, aesthetic use under simulated use conditions
 What should studies permit an assessment of?, the probability of an inadvertent deposition of energy into distal and/or surrounding non-target tissue
 What should preclinical animal studies follow?, modern practices of humane care and use
 What will the FDA rely on instead of requiring clinical studies?, well-designed bench and/or animal testing
 What is the use of a dissimilar ultrasound stimulator system for aesthetic use?, indications for use dissimilar from a legally marketed system of the same type
 What is a significant portion of the target popul?, aesthetic
 What is the name of the book that Burch wrote about the principles of humane Experimental Technique?, The Principles of Humane Experimental Technique
 What is the name of the regulation that requires a clinical study to demonstrate substantial equivalence?, Investigational Device Exemptions (IDE)
 What may lead to differences in the injection 399 angle?, changing the 397 dimensions and materials of the rear and front shell subassemblies’ internal 398 components
 What must sponsors of trials comply with in addition to having an FDA-approved IDE?, regulations governing institutional review boards
 What is the name of the FDA-recognized standard?, EMC
 What does IEC 60601-1-2 stand for?,
 What does IEC 60601-1-2 stand for?, Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic compatibility – Requirements and Tests.
 What must labeling satisfy the requirements of?, 21 CFR 807.87(e)
" What must include, however, adequate information for practitioner use of the device?", Labeling
 What do you recommend users with open wounds or lesions not to use?, the device
 What must be included in the user manual?, storage conditions
 What should be included to ensure complete handpiece skin contact and to not expose the eyes to ultrasound radiation?, a warning
 What should be identified for any laboratory tests or other evaluations?, laboratory tests or other evaluations
" What should be helpful in following the patient’s response or identify adverse reactions and, if appropriate, specify the frequency of such tests or evaluations before, during and after use of the device.?",
 What did the applicant not gather for the TBM product?, new clinical data
 What should all animal studies be designed based on?, modern practices described in the following references
 What is the name of the act that expanded the use of animals in research?, Public Law 99-158 “Animals in Research”
 What is the name of the guide for the care and use of Laboratory Animals?, National Research Council
" What is the phone number for Patricia Y. Love, MD, Office of Combination Products?", 301-427-1934
 What is the name of the Office of Combination Products?, OCP
 Where can you submit electronic comments for the FDA?, http://www.fda.gov/dockets/ecomments
 What is the definition of combination products?, 3 A. Definition
 What is the name of the guidance that represents the Food and Drug Administration?, Guidance for Industry and FDA Staff
 What does the approach satisfies the requirements of?, applicable statutes 8 and regulations
 What is the purpose of this document?, provide a context for initial discussions on the type of scientific and technical information that 16 may be necessary for investigational or marketing applications for these combination products
 What was the TBM device tested in accordance with?, relevant 406 standards
 What is CDRH?, Center for Devices and Radiological Health
 What is the Center for Devices and Radiological Health?, Center for Biologics Evaluat
 What is the Office of Combination Products called?, Office of Combination Products
 What can be used in combination to potentially 37 enhance the safety and effectiveness of either product used alone?, Drug and biologic products
 What provides a new route of insulin delivery 40 that may decrease the need for insulin injections.?,
 What does FDA recognize that combination product development may raise a number of?, Critical Path4 49 challenges
" What may need to be developed for manufacturing, evaluation 54 of preclinical safety in targeted areas of the body, or clinical trial design to establish sa?", New methodologies
 What does FDA believe is important to address?, scientific and tech
 What are the issues raised by innovative combination products?," safety, effectiveness, and quality of the combination product"
 What is a summary of the workshop available at?, http://www.fda.gov/oc/combination/workshop070803.html
 What is the name of the example of the drug that could affect the delivery?, Injection time
" What is a drug, device, and a biological product?"," 68 drug, device, and a biological product"
" What is the intended use of a drug, device, or biological product?"," intended for use only with an approved 80 individually specified drug, device, or biological product"
 What is a constituent part of a combination product for purposes of this guidance?, an article in a 92 combinat
 What is the public health service act?," 42 U.S.C. 252 (i), Public Health Service Act"
 What is the OCP?, Office of Combination Products
 What does OCP ensure timely and 107 effective premarket review by overseeing the timeliness of and coordinating reviews involving 108 more than one agency center?,
 What is the PMOA of a device-biologic combinat?, the primary mode of action of a combination 115 product that provides the most important therapeutic action of the combination product
 What is the final 119 regulation also included?, assignment algorithm
 What is the lead center responsible for?, the review and 124 regulation of the combination product
 What is the goal of the SOP?, ensure timely and 132 effective intercenter communication on combination products
 What did the applicant identify that can be applied to the modified TBM 426 autoinjector?," the dose accuracy, delivery time, injection 429 depth, injection angle"
 What is the FDA's recommendation for developers to contact for assistance in determining the assignment of a lead center?, OCP
 What is the suffix for most combination products?, a single marketing application
 What may determine that two marketing applications are necessary?, FDA
 What does FDA encourage applicants who are uncertain as to whether a single or multiple marketing applications should be submitted for a combination product to discuss?, the answer: FDA encourages applicants who are uncertain as to whether a single or multiple marketing applications should be submitted for a combination product to discuss the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer:
 What is the postmarket regulations called?, adverse event reporting
 What does combination product development typically focus on?, scientific and technical issues raised by the particular product being developed
" What is the breadth, innovation and 155 complexity of combination products?", there is no single developmental paradigm appropriate for 156 all combination products
 What is the guidance for preclinical evaluation of drugs/biologics different from?,161
 What does FDA recommend that 165 developers consider?, the scientific and technical issues raised by the combination product and its 166 constituents
 What is important for a drug eluting stent?, mechanical attributes of the polymer 174 coating system that contains the drug substance
 What has the applicant determined that the PK studies conducted using Prototype 1 of the autoinjector 432 can be leveraged?, the applicant 431
 What is the purpose of the guidance document?, to deliver a drug/biologic to a new area of the body
 What is the name of the new method that the OCP uses to determine the effect of localized/targeted delivery?, Nonbinding Recommendations 182
 What should combination product developers consider when developing information to demonstrate the safety and effectiveness of a combination product and its constituent parts?, general principles
 What may lead to a more targeted and efficient development pathway for 197 the co?, Consideration of these issues in the context of 196 existing guidance documents
 What is a good starting point for considering the appropriate data to establish safety and 204 effectiveness for its use in a combination product?, Prior FDA approval and/or clearance of a particular constituent part
 What is needed to address the scientific and technical issues raised by the 211 new use of the constituent in the combin?, additional 210 data and information
 What is the cid:131) Is the indication for a given constituent approved?, Is the indication for a given constituent
 What is the intended target population of the combination product?,221
" What is the cid:131) Are the device and drug constituents chemically, physically, or otherwise combined into 229 a single entity?",229
 What is a drug constituent that is a new molecular entity?, a drug constituent
 What is the applicant determined to be the same?," the applicant has determined that the 443 nonclinical, toxicity, and safety and effectiveness data gathered in the e Answer: the applicant has determined that the 443 nonclinical, toxicity, and safety and effectiveness data gathered in the e."
 What is some safety and effectiveness testing of the device alone 249 necessary before or along with the studies to establish the safety and effectiveness of the 250 combination product as a whole?, the 250 combination product
 What would a combination product 253 incorporate?," an indwelling, intravenous drug delivery catheter"
 What may be necessary to establish the suitability of the device design to the new environment in which it 257 will be used?, New engineering or functional testing
 What could affect safety?, Presence of inactive breakdown products or manufacturing residues from device manufacture
 What is a drug constituent used together with?, an energy emitting device
 What is the FDA encouraged to seek early discussions with when exploring the application of st?, developers
 What is the first step in determining the safety and effectiveness of a new molecular entity when used in a combination product?, consideration of the 292 NME alone
 What is the information needed for combination of the NME and the device 294 constituent?, NME
 What are the studies submitted in?, the marketing application for the 300 product
 What is an example of a new preclinical or clinical safety information or new clinical studies?, 307 product
 What can be bridged to the Prototype 2 autoinjector presentation and leveraged?, Prototype 1 autoinjector presentation
 What is the name of the Guidance to Industry: Format and Content of Non-clinical Pharmacology/Toxicology Section of an Application?,
 What should the marketing application 315 316 contain?, appropriate data
 What is the extent that the combination product permits local or systemic drug exposure 324 that is greater than that occurring with approved dosing regimens?, greater
 What may be appropriate to evaluate the 326 local/regional toxicity of a drug/device combination product administered directly to targeted tissue?, New studies
 What might these studies be used to determine?, drug release kinetics
 What is the toxicity profile of the combination product?, NOAEL
 What is the name of the new route of administration of 348?, local toxicity
 What is the ICH E1A?, The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
 What is the name of the IDE?, Investigational Device Exemption
 What is an alternative for exploring candidate products during research and development?, Exploratory IND Studies
 What is the name of the device that is not used in intra-operative procedures?, CADe devices
 What is the injection time of the TBM autoinjector?, 456 unchanged
 What is the FDA's recommendation for drug developers?, techniques to measure drug levels in areas not typically accessible
" What would such studies evaluate how users operate the system in realistic, stressful conditions?", how users operate the system
 What are important considerations during the development of a combination product?," Manufacturing considerations 388 389 Manufacturing, scale-up, and quality management17"
 What may be altered or destroyed by terminal sterilization tech?, Certain drug or biological product constituent parts
 What may affect the safety or effectiveness of the combination product as a 404 whole?," any potential 402 change in the manufacturing process for the drug, biologic, or device constituents or for the 403 combination product"
 What may vary with the time and methods used for cellular incubation before application to the device 408 constituent?, performance characteristics 407
 What is the name of the study that may be necessary to assess changes in the constituent parts and for the combination product as a whole?, testing specifications
 What does FDA encourage manufacturers to establish with manufacturers of constituent parts to maintain sufficient awareness of?, manufacturing changes in constituent parts
 What is the potential impact of a manufacturing change evaluated in a manner appropriate for the stage of combination product development?,422
 What may developers wish to provide in one marketing application?, all necessary information
 What does the applicant determine is not needed to be bridged?, existing information that may be 462 leveraged
 What is the name of the letter that would grant FDA permission to consider the referenced material in its review of the current application?, authorized cross reference from the owner of the 435 referenced material
 What is not a substitute for a master file?, A master file
 What is considered in the context of a particular investigational 451 or marketing application?, 450 information in a master file
 What is the name of the document that contains the information on drug master files?, 21 CFR 458 314.420
 What does early dialogue allow developers to obtain?, initial 468 feedback on the kinds of preclinical and clinical testing that may be necessary
 What is the purpose of the pre- 477 investigational meetings?, discussing innova
 What is the name of the organization that should be contacted to schedule meetings in accordance with the procedures and 485 milestones appl?, The lead center
 What is the OCP available for?, as a resource to developers and review staff throughout the lifecycle 494
 What is the CDRH Guidance web page accessible at?, 503 http://www.fda.gov/cdrh/guidance.html
 What is the FDA's guidance for Industry on how to write a Request for Designation?, Guidance for Industry and CDRH Staff
 What is the purpose of the side-by-side comparison of the user interface for the combination product using Prototype 1?, 469 comparison
 What is the OCP?, Office of Combination Products
 What is the address of the office that handles the design of combination products?," 10903 New Hampshire Avenue Silver Spring, MD 20993-0002"
 What is a Request for Designation?, Request for Designation
 What is the name of the FDA’s electronic su?, OCP
 What is the name of the section that provides contact information for sponsors?, 3.7(c)(1) 8
 What is the purpose of Section 3.7(c)(2)(vi)?, 8. Proposed Use or Indications
 What is the limit on the amount of pages a request for designation can be submitted to?, 15 pages
 What can you use if the approach satisfies the requirements of the applicable statutes and regulations?, an alternative approach
 What does OCP stand for?, Office of Combination Products
 What is the final rule defining the primary mode of action of a combination product called?, PMOA Final Rule
 What is Combination Product A indicated for?, the prevention and relief of 481 bronchospasm
 What is the FD&C Act's Section 563?, the FD&C Act
 What is the term that does not include combination products as defined in 21 CFR 3.2(e)?, non-combination product
 What is the purpose of the term “device”?," the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals"
" What is the purpose of a component, part, or accessory?"," (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,"
 What is the term biological product used for?," a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein"
 What is a combination product comprised of?, a combination of a drug and a device; a biological product and a device; a drug and a biological product
 What would need to be changed upon approval of the proposed product?, labeling of the approved product
 What is an RFD also referred to as an applicant’s letter of request?, an applicant’s letter of request
 What is a written submission to OCP?, RFDs
 What defines the term agency center as a center or alternative organizational component of the Food and Drug Administration?, Section 503(g) of the FD&C Act
 What is the purpose of Combination Product B?, an indication of prevention and relief of 485 bronchospasm in patients 4 years of age and older with reversible obstructive airway disease
 What is a potential stay of the review clock if the classification or assignment of the product under Answer: Answer: unclear or in dispute?,
" What is the definition of a product that has different configurations, ingredients, and/or proposed?", product families
 What do we encourage you to contact before submitting my RFD?, OCP
 What can you request prior to submitting an RFD?, a meeting
 What is the determination pertains only to the product described in the designation letter?, the product
 What is the RFD process outlined in?, 21 CFR Part 3
 What will OCP review within 5 business days of its receipt of an RFD?, the submission for completeness and determine whether the RFD contains the required information
 What is the date by which FDA plans to respond to the RFD?, acknowledgement letter
 What is the ssignment section of the FD&C Act?, 21 CFR 3.8(b)
 What is the maximum amount of information that cannot be included in your original RFD?, five pages
 What is the purpose of the combination products 489 products?, to rapidly reverse bronchospasm
 What is the name of the agency that can be reached by contacting OCP?, OCP
 What is the name of the section that requires you to include the following information in an RFD?, Section Answer: Section: What information must I include in my RFD
 What is the name of the sponsor?, company name and address
 What is the name of the sponsor of the product?, sponsors
 What is the name of the sponsor’s identification of the single mode of action that provides the most important therapeutic action of the product?, sponsor
 What format should I follow for my RFD?, format and organization desc
 What is the standard typeface for an RFD?, Times New Roman
 What should the envelope be clearly marked as in order for the RFD to be sent to the correct location?,
 What is the common electronic format for RFDs?, Portable Document Format (PDF)
 What information does FDA recommend that sponsors provide in RFD submissions?, Sponsors must provide the information required in 21 CFR 3.7
 What must you include if you have chosen a proprietary name for your product?," company establishment registration number (if applicable), and telephone number"
 What is the tric age 495 group?,495
 What must you include in your RFD?, description of the Product
 What does Section 3.7(c)(2)(iv) require?, prior Approvals and Agreements
 What section of the FD&C Act does a device exempt from premarket notification requirements?, 510(k)
 What is the name of the section of the FD&C Act that requires a new drug application to be submitted to the FDA?,505
 What must you include in your submission according to 21 CFR 3.7(c)(2)(v)?," chemical, physical and/or biological composition"
 What is important for the appropriate classification and jurisdictional assignment of your product?, PMOA of a combination product
 What section of your RFD is critical?, proposed use or indications
" What is the mode of action of a drug, device, biological product, or combination product?", PMOA
 What is a mode of action?, the means by which a product achieves an intended therapeutic effect or action
 What is an icle?," biological product, device, or drug"
 What is the applicant's decision about the user interface?," the uses, and environments of use of the products is unchanged"
 What is the mode of action expected to make the greatest contribut?, mode of action
 What must you identify if your product is a combination product?, the mode of action that you believe to be the single mode of action that provid
 What must you include in your argument?, the basis for why you think that action is the most important
 What should you provide if you choose to cite “in press” literature?, copies of the referenced material
 What should be included in the 15 page RFD?, information or data which is only available in your company’s internal research report(s)
 What is the basis for your conclusion?, Which mode of action makes the greatest contribution
 What is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the product?, mode of action
 What is the PMOA of a combination product complicated for?," products where the product has two completely distinct therapeutic effects achieved by completely different modes of action, neither of which is subordinate to the other"
 What is the first step of the assignment algorithm?," if there are other combination products that present similar questions of safety and effectiveness with regard to the combination product as a whole, the Agency will assign the combination product to the Agency component that regulates those other combination products."
 What is the second step in the RFD?, under which we would assign the combination product to the Ag Answer: the Ag Answer: the Ag Answer: the combination product
 What did ysis create between Combination Products A and B?, a bridge 512 for adult user interface information
 What are the factors listed below intended to further illustrate?, the kinds of issues that may be relevant when determining whether a new combination product presents safety and effectiveness issues similar to those presented by a previous combination product
" What allows the Agency to take into account technological developments, evolving scientific understanding, and specific factual information concerning the particular product?", case-by-case analysis
 What is a drug constituent part a new molecular entity or new formulation?, a drug constituent part
" What is another of the constituent parts that presents more significant safety and effectiveness issues relating to the risks it poses, its effectiveness, or its novelty?", presents more significant safety and effectiveness issues
 What must you do if you cannot determine with reasonable certainty the most important therapeutic action of your combination product?, recommend an assignment for your product based on the assignment algorithm
 What should you identify any other combination products that you are aware of that you believe FDA should consider in determining the assignment of your product?, any such other combination products that you are aware of that you believe FDA should consider in determining the assignment of your product
 What should you identify if you do not believe your product is similar to another combination product?, ontact lens
 What should the Agency explain in their opinion to the Center that has the most expertise related to those questions?, which Center has the most expertise
 What are the most significant safety and effectiveness questions raised by the vision-correcting contact lens?," the characterization, manufacturing, and clinical performance"
 What does the applicant determine is the same with Combination Product A?, the materials remain the same
 What should an RFD say about a wound dressing?, the dressing should be used over a four-hour period
 How many days does a period of time not to exceed?, 10 days
 What would you identify in a combination product wound dressing?," the specific amount of the drug contained in the device, and that it would be applied topically to the specific type of wound your product is intended to treat"
 What should you describe if your product is an injectable product?, the amount of product being injected and the site of the injection
 What is the product application number?, 510(k) or NDA number
" What is often helpful in describing the product, its components, and its modes of action?", literature references
 What should your classification recommendation be based on?," composition, mode(s) of action, and intended use(s) of your product"
 What should you state if you believe your product is a combination product?," what type of combination product it may be (e.g., drug/device) and your rationale for this recommendation"
 What is the algorithm used to make a recommendation of a lead center?, 21 CFR 3.4(b)
 What is the most important section of an RFD summarized in?, Section IV
 When is the premarket notification issued?," January 22, 2020"
 What is the 21 CFR classification of computer-assisted acquisition/optimization devices?,892.21
 What is the intended patient population for Combination Product A?, change in drug
 What do you think your product should be classified and assigned?," how do you think your product should be classified and assigned, and why"
 What is the name of the sponsor?," The identity of the sponsors, and the status of any discussions or agreements between the sponsors regarding the use of this product as a component of a new combination product"
 What is the description of the manufacturing processes?, Description of all known modes of action
 What must the sponsor's recommendation be based on?, assignment algorithm
 What is the name of the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document in the review of PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: most expertise related to the most significant safety and effectiveness questions 1 7 Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process?,
 What is the name of the office that handles the application of this guidance to devices regulated by the Center for Biologics Evaluation and Research?," Office of Communication, Training and Manufacturers’ As Answer: Nicole L. Wolanski"
 What is the name of the division that the Food and Drug Administration has in charge of dockets management?," Division of Dockets Management, Food and Drug Administration"
 What is the name of the center that provides guidance on radiological health?, Center for Devices and Radiological Health
 Where is the document number for this document?," Office of Communication, Training and Manufacturers Assistance (HFM-40)"
 What is the least Burdensome Approach?, PMA Supplement
 What is the purpose of the HF validation study report?, produce a HF validation study report
 What is OIVD?, Significant Modification of Technology
 What is the change in Indication for Use - Different Surgical Procedure 10 B6.?,
 What is the name of the new device Feature?, CBER
 What is the name of the alternative supplier of critical component?, OIVD
 What is the name of the Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval?, Guidance for Industry and FDA Staff
 What does not create or confer any rights for or on any person and does not operate to bind FDA or the public.?,
 What is the purpose of this guidance document?," to establish a clear and consistent way to approach the decision-making process you follow to determine the type of regulatory submission, if any, that may be required when you modify your lawfully marketed PMA device"
" What is the section 515 of the Federal Food, Drug, and Cosmetic Act?", section 515
 What does the guidance provide examples of?, various types of device modifications
 What is the purpose of modifying a PMA device in response to a recall?, to assure the continued safety and/or effectiveness of the device
 What is the name of the division that evaluates neurostimul?, Neurological and Physical Medicine Devices Neurostimul
 What does the word should mean in Agency guidance documents?," something is suggested or recommended, but not required"
 What does this guidance reflect?, our careful review of the relevant scientific and legal requirements
 What is the term used to describe the requirements for periodic reporting?, continuing evaluation
 When was the draft version of this guidance document issued?," March 9, 2007"
 What was the response of industry to the August 1998 draft guidance?, FDA’s response
 What was the MDUFMA's name?, Medical Device User Fee and Modernization Act of 2002
 What did Industry request?, a detailed flowchart
 What did FDA provide where possible?, additional clarity for some terminology
 Why has FDA chosen not to include 30-day supplements within the scope of the guidance document?, because we have not identified cases for which this provision can be effectively applied
 What is the general requirement for when a PMA supplement is needed?, 21 CFR 814.39(a)
 What is the name of the branch that handles electronic comments?, Devices Branch
" What is the use of a different facility or establishment to manufacture, process, or package the device?"," manufacture, process, or package the device"
 What is the name of the periodic report that reports a change to a manufacturing procedure or method of manufacture that has been approved by FDA?, 21 CFR 814.39(b)
 What does the QS regulation require of you?, have in place a system to document and assess design changes
 What is the primary indicator of what type of PMA submission is needed?," the nature of the data, if any, that is needed to demonstrate the safety and effectiveness of the modified device"
 What do we believe are needed to support the safety and effectiveness of such changes?, general nature of test data
 What is the OIVD?, Safety
 What is the purpose of the examples in this document?, to demonstrate the underlying principles
 What is the term for in vitro diagnostics?, IDDs
 What should you do when deciding whether to submit a supplement to your approved traditional PMA or to submit a new traditional PMA5 for a modified device?," ascertain whether, and to what extent, you can rely on the preclinical testing and clinical data submitted in your traditional PMA to support the safety and effectiveness of your modified device."
 What does each example describe?, a device revie
 What is the name of the Biological Markers and Clinical Endpoints?, 6 1. Biomarker Tests
 What is the procedure where the chest is opened by surgical incision?, TransMyocardial Revascularization (TMR) holmium laser
 What is the laser penetrating entirely through the wall into the ventricular cavity?, hole
 What is the term used to describe a study using a patient population with a defined clinical condition to determine the safety and effectiveness of the device?, clinical data
 What is the PMA that is used in place of a traditional PMA?, modular PMA
 What is PMR?, a non-surgical procedure
 What was needed to assess the impact of the change in the device?, new preclinical testing
 What was the purpose of the PMA?, Because new preclinical and clinical data were necessary to demonstrate a reasonable assurance of safety and effectiveness for the modification
 What did the PMA applicant modify the lead by adding a steroid eluting piece to the distal lead tip to reduce?, the inflammatory process
 What did the modified lead design raise questions about?, longer battery life and lower stimulation threshold
 What was needed to demonstrate that the steroid-eluting lead remained as safe and effective as the approved non-steroid lead?, New preclinical and clinical data
 What is IDEs?, Neurological Devices Targeting Disease Progression and Clinical Outcomes
 What was the PMA meant to detect?, total prostate-specific antigen (total PSA) in serum
 What were the analytical performance characteristics of the two assays?, differ
 What is the OIVD?, Significant Modification of Technology
 What is the name of the membrane-bound EIA?, membrane-bound EIA
 What is the term for a panel-track supplement?, d
 What is the MDTCA?, Medical Devices Technical Corrections Act
 What describes when a Panel meeting may be held?, 21 CFR 814.44
 What is the term for a new clinical data set that is intended to provide valid scientific evidence necessary to support the safety and effectiveness of the modified device?,substantial clinical data
 What is a nonbinding recommendation about the intended patient population?,
 What would generally require significant labeling changes?, Changes in these clinical aspects
 What is the most appropriate supplement type for a change in indication for use or a change to (or removal of) a contraindication of the device?, panel-track supplement
 What does novel treatments revolutionize?, how neurological diseases or conditions are treated
 What is the FDA's view of a change in indication?, indication or contraindication changes generally do not require or require very limited new preclinical testing
 What was the VAD indicated for?," temporary, mechanical circulatory support of nonreversible left ventricular failure in patients awaiting cardiac transplant"
 What are the two patient populations?," destination therapy patients are precluded from a transplant because they do not meet the age requirement or they have one or more co-morbid conditions (e.g., diabetes)."
 What was needed to demonstrate reasonable assurance of safety and effectiveness for longer term implantation?, New clinical data
 What was the original PMA tested for?, safety and effectiveness
 What was needed to support the safety and effectiveness of the device?, new clinical data
 What was the original indication for urethral strictures?, the device is inserted into the bulbar urethra in order to improve urine flow and prevent recurrence of strictures
 What is the new target patient population's risk related to?," age, overall health and anatomical location where the device is to be used"
 What is the risk of adverse tissue response due to the presence of the stent in hyperplastic tissue?, presence of the stent in hyperplastic tissue
 What was the PMA approved for?, high frequency oscillatory ventilator
 What is the FDA's role in the clinical trials of medical devices targeting neurological disease progression?, conduct clinical trials
 What was the new indication for adults with adult respiratory distress syndrome?, adults with adult respiratory distress syndrome
 What was needed to evaluate the safety and effectiveness of the device in the new population?, new clinical data
 What did the PMA applicant modify to add pediatric patients?, the indication for use
 What was the purpose of the new clinical testing?, to demonstrate that the device provided reasonable assurance of safety and effectiveness for the new pediatric patient population
 What is nearsightedness?, myopia
 What were concerns associated with the intrastomal ablation used in the new indication?, new risks and clinical effectiveness concerns
 What was the PMA approved for?, a soft silicone hydrogel extended wear (1 to 7 days) contact lens indicated for the correction of myopia or hyperopia
 What was the new safety concerns raised by the extended time of wear?," increased risk of ocular adverse events, such as corneal microbial keratitis, and corneal infiltrated lesions"
 What was the PMA applicant's original use?, HIV diagnostic
 What did the actual analyte do?, did not
 What is the CDRH's focus?, the cause or progression of the neurological disorder or condition
 What was the PMA applicant modified to include?, the mitral position
 What can physiological and potential performance differences between the two positions significantly impact?, clinical outcome
 What was not needed because the test data provided in the original PMA were sufficient to support the valve for use in the mitral position.?,
 What is required for certain types of significant changes to the approved device that affect safety or effectiveness of the device?, Submission of a 180-day supplement
 What is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device?, new preclinical testing
 What is the most common type of clinical data that FDA believes is appropriate for a 180-day supplement?," a limited number of patients, shorter study duration, and/or a subset of endpoints"
 What is the name of the change FDA approved for a device modification?, C1. Design Change
 What is a VAD intended for?, temporary mechanical circulatory support for patients awaiting a cardiac transplant
 What was the deadline for the submission of the 180-day supplement?, 180-day supplement
 What did FDA determine was adequate to demonstrate reasonable assurance of the safety and effective?, preclinical testing
 What is the purpose of this guidance?, We recommend that you use this document to help determine the types of data that may be needed to support an IDE application and to help in the design of clinical trials.
 What did the PMA applicant add to the chemical formulation of the lens?, ultraviolet (UV) light blocking material
 What was the reason FDA determined that the submission of a 180-day supplement was appropriate for this change?, to demonstrate a reasonable assurance of the safety and effectiveness of this modification
 What was needed to demonstrate that the modified device met the specifications of the original device?, comparative bench testing
 What was the name of the new automated analyzer used in the PMA?, OIVD
 What was appropriate for this change?, a submission of a 180-day supplement
 What impacted the electrical characteristics of the device?, These changes impacted the electrical characteristics of the device
 What did FDA approve for an endovascular stent graft system?, PMA
 What was the new graft woven into?, a denser weave configuration
 What was the submission of a 180-day supplement appropriate for?, this change
 What was needed to assess the performance of the modified device?, verification and validation testing
 What is the name of the CADe device that is not subject to the guidance?, non-CADe devices
 What does the word should mean in Agency guidance?," something is suggested or recommended, but not required"
 What was FDA's PMA for?, pneumatic ventricular assist device (VAD)
 What was the PMA applicant's primary concern?, heart failure awaiting a cardiac transplant
 What was sufficient to demonstrate reasonable assurance of safety and effectiveness of the modified device?, new bench testing and the limited confirmatory clinical study
 What was the purpose of the PMA?," HIV diagnostic intended for fingerstick, whole blood specimens"
 What was the FDA's recommendation for a 180-day supplement?, The clinical data necessary to support the modification was limited
 What is the name of the document that provides information about the process for the real-time review program?, Real-Time Premarket Approval Application (PMA) Supplements
 What is the FDA not aware of when a real-time PMA supplement would be appropriate for changes that affect an indication for use?, a situation in which a real-time PMA supplement would be appropriate
 What was the test method previously accepted by FDA?, test method
 What was the ientific discipline of electrical engineering?, electrical engineering
 What was the upper limit for the storage temperature for bone graft?, 25°C
 What is the purpose of clinical trials that investigate neurological devices using biological markers and clinical outcome assessments?, general study design considerations
 What was the new higher temperature sufficient to support the change?, Stability data
" What was performed to evaluate the physical, chemical, and biological stability of the device during storage?", Accelerated and long-term testing
 What was the PMA applicant proposing to modify?, excimer laser system
 What scientific discipline was sufficient to support this minor change?, electrical engineering
 What did the FDA approve for its alternate wet shipping solution?, o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o: PMA applicant proposed to use an alternate wet shipping solution for its permeable extended wear contact lenses.
 What was the concern with the new solution?, compatibility with the contact lens
 What was the single scientific discipline of?, mechanical engineering
 What does 21 CFR 814.39(d)(1) and (d)(2) provide?, certain labeling and manufacturing changes that enhance the safety of the device or the safety in the use of the device may be submitted as a supplement marked “Special PMA Supplement – Changes Being Effected.”
 What is a condition of prior FDA approval?, lawful distribution
 What does the FDA allow for safety-related warnings for which there is reasonable evidence of a causal association?, safety-related warnings
 What is an intermediate endpoint?, a clinical endpoint concerning a symptom or measure of function that is not the ultimate outcome of the disease
 What is the final rule published by FDA?," Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices"
 What does the limited Special PMA Supplement possesses when it possesses new information that provides a scientifically legitimate foundation for modifying the FDA-approved labeling?, the applicant may place the change in effec
 What does the PMA supplement provide about the basis for the changes?, full explanation
 What should be considered temporary while FDA reviews the supplement?, how the change enhances the safety of the device or the safety in the use of the device
 What is the regulation allowing both labeling and manufacturing changes that enhance the safety of the device?, 21 CFR 814.39(d)(2)
 What is the most common reason for a manufacturing change to be reviewed as a Special PMA Supplement?, to enhance safety but not to impact effectiveness
 What is the most appropriate type of supplement if the quality control or manufacturing process change impacts the device specifications and/or performance of the device. Special PMA Supplement?,
 What was the reason for a Special PMA Supplement?, Because this modification to the warning of the labeling enhanced safety with no impact on effectiveness
 What did the PMA applicant add to the manufacturing process to help with the source wire component of its intravascular brachytherapy system?, a secondary wipe station
 What was the PMA applicant's reason for making the urethral stent labeled change?, enhanced safety with no impact on effectiveness
 What is an intermediate endpoint used as a substitute for?, a clinical endpoint
 What did the manufacturing process of a duett sealing device ensure?, a tight fit between the two mating parts
 What was the source of the error message?, A greater than normal air gap between two inductors on one of the circuit boards
 What is the name of the Act that allows a PMA applicant to submit written notification to the agency of a modification to the manufacturing procedure or method of manufacture affecting the safety and effectiveness?, FDAMA
 How long may the applicant distribute the device after the date on which FDA receives the notice?, 30 days
 What is the name of the guidance document that contains Nonbinding Recommendations?, 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes
 What is the PMA applicant's manufacturing process for a cardiac resynchronization therapy pacemaker called?, CRT-P
 What was the PMA applicant's qualified supplier for the manufacture of a critical component used in the calibrator of its Hepatitis B surface antigen assay?, OIVD
 What is PMMA used for?, manufacture of a single-piece intra-ocular lens
 What was the 30-day notice converted to?, 135-day supplement
 What did the PMA applicant make a change that included moving the in- process quality control monitoring step for endotoxin to a different location in the process flow?, The PMA applicant provided adequate documentation in the 30-day notice to support this change in the manufacturing process of the prosthesis
 What is sometimes used as endpoints in trials of antihypertensive therapeutics?, blood pressure measurements
 What was the 30-day notice converted to?, a 135-day supplement
 What was the time period in which the PMA applicant submitted a change to incorporate an alternate backup deployment test methodology in its manufacturing process?, 135-day supplement
 What is the term for release based on demonstrating no growth of biological indicators?, n parameters
 What are the 180-day supplements called?, Manufacturing site change supplements
 What describes the criteria for manufacturing site change supplements and when an inspection would likely occur?, CDRH intends to issue a separate guidance document
 What is the expectation for a manufacturing site change supplement?, for a manufacturing site
 What is required of a PMA applicant after approval?, to submit reports to FDA annually
 What is the term used to refer to periodic reports by FDA and industry as?, periodic reports
 What does not need to be reported in the annual report because the Agency did not believe that these impact safety or effectiveness?, changes
 What does not impact the safety and effectiveness of the device?, Reducing a maximum temperature specification
 What are some examples of neurological diseases?," Alzheimer’s disease, Parkinson’s Disease, or Primary Dystonia"
 What was the restricted range optimal for?, low processing times and high yields
 What is the tolerance limit?, 0.4°C
 What did the olerance limits provide?, additional assurance of device quality
 What was previously validated and incorporated in the pump manufacturing process?, non-automated test
" What is a minor change to the device, Changes in labeling, Changes to a The use of a different in design or components, materials, such as a minor change to the quality control, or manufacturing facility or performance of the design, specification, design of the device, software, manufacturing processes procedure or establishment to device, or a new software, color additives, sterilization, or labeling?",
 What is the MDTCA?, Public Law 108-214)
 What is the main reason for a change in labeling?," to strengthen, or delete effectiveness"
 What is the additional assurance of clinical data to support?," FDA-accepted test method, purity, identity, strength, the change"
 What is the main purpose of the modification?, Identify the modification and reason for it
 What may or may not agree with your asses?, Changes Being Effected A FDA may or may not agree with your asses
 What is the reason for patients forgo currently approved treatments in earlier stages of disease?, patients forgo currently approved treatments
 What is the name of the person who can be contacted for questions regarding the OIVD document?, Kyle J. Myers
 What is the name of the division that handles dockets?, Food and Drug Administration
 Where can you obtain a hard copy of the guidance?, 301-847-8149
 What is the name of the Detector?, Flat Field Correction
 What is the name of the system that generates X-rays?, X-ray Generator
 What is the name of the ELECTRICAL SAFETY?, 6 6.
 What is the name of the device that is being tested?, PHANTOM TESTING
 What is class II of full-field digital mammographic devices?, special controls
 What does the classification regulation designate this guidance document as?, the special control
 What does the firm need to show that its device addresses the issues of safety and effectiveness identified in this guidance?, The firm will need to show that its device addresses the issues of safety and effectiveness
 What are biomarker tests that rely on biological imaging assessments called?, MRI
 What must a manufacturer do to ensure the safety and effectiveness of full-field digital mammography devices?," conform to the general controls of the FD&C Act, including the premarket notification requirements"
 What is the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807.81?, 21 CFR 807.87
 What is the scope of this document limited to?, FFDM systems
 What is a full-field digital mammography system intended to produce?, planar digital x-ray images of the entire breast
 What is the FDA guidance document entitled?, Class II Special Controls Guidance Document: Full-Field Digital Mammography System
 What is the acquisition work station used for?, acquisition work station
 What is the detector readout device?, removable solid state detector
 What is the class of devices that display accessories to an FFDM System?, class II
 What should you identify your device by in a 510(k) premarket notification?, regulation and product code
 What is the (device name) intended to be used in the same clinical applica?, The (device name)
 What may require longer periods of time to evaluate?, clinically meaningful outcomes
 What is the screening use of an FFDM system?, An FFDM system can be indicated for screening use only or for both screening and diagnostic uses
 What is the amorphous silicon with deposit of cesium iodide?, cesium iodide
 What is the size of active area?, pixel dimensions and fill factor
 What is the flat-field correction procedure called?, the flat-field correction procedure
 What is the ADC?," bit depth, matrix size, and pixel width"
 What is SID?, source to patient support device distance
 What should you describe for the x-ray tube if manufactured by a third party?, trade name and model
 What is the AEC detector used for?, low level pre-exposure
 What is acceptable if an alternative method is chosen?, it should be described completely
" What should describe the paddle types, sizes, geometries, and materials?", breast compression system
 What should be well established evidence and agreement in the clinical community that the chosen biomarker test reflects a characteristic that is important to 6 the underlying disease process and that it is associated with a?, the chosen biomarker test
 What is the level of concern?, the risks associated with software failure
 What is the replacement for film cassettes for detectors intended to be used with conventional mammographic x-ray systems?, computed radiography (CR) plate/reader/display systems
 What is the radiation dose a function of?, breast thickness and composition
 What measures are described in this guidance document?, measures recommended to mitigate these identified risks
 What is the name of the standard that should be used to evaluate the electrical safety of your device?," Clinical Image Evaluation 8. Physical Laboratory Testing Inadequate breast coverage 9. Clinical Image Evaluation Excessive x-ray exposure 8. Physical Laboratory Testing Inappropriate breast compression 8. Physical Laboratory Testing 7. Biocompatibility Testing Infection, skin irritation 10. Labeling 6. Electrical Safety You should evaluate the electrical safety of your device according to the following standards or use equivalent me Answer:"
 What is the Collateral standard?, Safety requirements for medical electrical systems
 What should you assess in your physical laboratory?, imaging characteristics of your system
 What should you describe as general guidance for these tests?, all phantoms
 What is a phantom?, Mammography Accreditation Program (MAP) phantom
 What should be performed under conditions that match the intended clinical use of the system?, testing
 What is the system code NFJ?," System, Image Management, Ophthalmic"
 What is the MDDT program?, The FDA’s Medical Device Development Tools
 What should you report if you were to assess imaging performance?," the trade name, characteristics"
 What should you provide quantitative data on?, sensitometric response
 What is the NPS?, noise power spectrum
 What is the measure of the efficiency of signal-to-noise ratio?, SNR
 What is the exposure level chosen from those used in clinical practice called?, the “reference” level
 What should you provide a quantitative measure of?, dynamic range
 What is a function of the number of erasures and exposures?, tests of image retention
 What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images?,
 What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images?, Repeated Exposure Test
 What should you provide to evaluate AEC performance?, data sets for a range of thicknesses from 2 to 6 cm of a homogeneous material at standard mode and magnification mode if available
 What should be provided for imaging of the ACR MAP phantom and for the wax target plate of the phantom?,
 What should clinical outcome assessments consist of?, direct quantitative measurement of the effect of a treatment upon disease progression and its impact upon the patient
 What should be included in the results of the AEC system if it has more than one mode of operation?, Exposure conditions and dose
 What is a C-D diagram?, a plot of the minimum detectable target thickness or contrast as a function of target size
 What is the k factor not greater than?, 80 m2
 What is the minimum exposure level for FFDM devices?, 21 CFR 892.1950
 What should your testing simulate?," 2, 4.2, and 6 cm thick compressed breasts"
 What is the resulting patient radiation dose?, exposure level at the entrance surface of the phantom along with the resulting patient radiation dose
 What is the minimum and maximum powered compression?, Breast Compression System
 What is the purpose of this evaluation?," to determine if the FFDM images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable quality for mammographic usage that they are substantially equivalent in safety and effecti"
 What is the new device substantially equivalent in safety and effectiveness to?, laboratory performance of the predicate device
 What are the names of the craniocaudal and mediolateral oblique views?, craniocaudal (CC) and mediolateral oblique (MLO) views
 What should be considered when developing clinical effectiveness endpoints?," The patient population, the nature of the underlying condition, and how they will be studied over time"
 How many expert mammographic radiologists should review clinical images submitted for MQSA accreditation?, two
 What is the verall assessment of whether these image sets collectively are of sufficiently acceptable quality for use in clinical mammography and to allow determination of substantial equivalence to a predicate device?, breast positioning
 What should the associated information include for each image?," compressed breast thickness, x-ray exposure conditions (anode, filter, kVp, mAs, exposure, half-value layer), and estimated dose"
 What should be fully explained by the expert mammographic radiologists?, mammography quality control manual
 What must labeling satisfy?, 21 CFR 807.87(e)
 What should be discussed with the precautions regarding the potential for adverse events associated with the use of the device and mitigation measures?," The adverse events should include: • excessive breast compression; • excessive x-ray exposure; • electric shock; • infection; and • skin irritation, abrasions or puncture wounds"
 What should you list for detector-only systems?, the x-ray system specifications and performance requirements
 What is the purpose of the ation dose?, to be used to verify proper AEC performance
 What should you include a summary of?, sensitometric response
 What is the patient population used for?," age, ethnic origin"
 What should labeling of the device be consistent with?, manner in which it was studied
 What should be encouraged in the instructions?, local/institutional training programs
 What is the AEC?, Automatic Exposure Control
 How long have you been practicing radiology since residency?, at least five years
 What is the name of the department that evaluates Cardiovascular Devices?, Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Cardiovascular Devices Cardiac Electrophysiology and Monitoring Branch 1 Preface Public Comment: What is the name of the department that evaluates Cardiovascular Devices
 Where can you submit electronic comments for Agency consideration?," Division of Dockets Management, Food and Drug Administration"
 Where can you get ional copies of the guidance?, the Internet
" What does not apply to electrodes or dispersive pads used for defibrillation, pacing, or cardioversion?", This guidance
 What does this guidance document describe?, a means by which ECG electrodes may comply with the requirement of class II special controls (513(a)(1)(B) of the act
 What must a manufacturer submit to provide equivalent assurances of safety and effectiveness?, a 510(k)
 What must a class II device comply with as a class II device?, general and special controls
 What is a disease-altering benefit?, treatment of the underlying disease or condition
 What does FDA recommend that manufacturers document how they address the recommendations in their design history file?, how they address the recommendations in this special controls guidance
 Who does not need to submit a 510(k) to FDA and receive agency clearance prior to marketing a device of this type?, persons who intend to market a device of this type
 What is the scope of this document limited to?, ECG electrodes
 What are generally used to deliver a small amount of alternating current with a high frequency?, Bioimpedance electrodes
 What is the scope of electrodes used for?, external pacing or other treatment effect
 What is the FDA recommend to mitigate the risks identified in this guidance document?, 5 Recommended mitigation measures Identified risk Adverse tissue reactions to the skin-contacting Section 5. Performance Characteristics electrode materials Section 6. Labeling Section 5. Performance Characteristics Misdiagnosis Section 6. Labeling Section 5. Performance Characteristics Electrical shock 21 CFR 898 P Answer: FDA has identified the following risks to health associated with the use of the ECG electrode.
 What must you maintain for each type of device?," device specifications, including appropriate drawings"
 What should be included in the cription?, a listing of all features and specifications of the device (a tabular format is desirable)
 What is the 21 CFR 820.20?, Quality Systems Requirements
 What is the type of electrodes?, bare
 What is the FDA's recommendation for early engagement with CDRH?, to obtain more detailed feedback
" What should not cause an irritating, sensitizing or cytotoxic effect upon the skin?",
" What should not allow irritating sensitizing, or cytotoxic materials to enter the skin by iontophoresis?", electrodes
 What is the electrolytic composition of some electroconductive gels that contain high levels of saline?, saline
 What should the design of the electrode ensure?, it will adhere to the patient’s skin for the duration of use compatible with the intended use of the device
 What do you test if the electrode is intended to be used on a diaphoretic patient or during strenuous exercise?, adhesive performance
 What should monitor the critical parameters of your final finished disposable ECG electrode to assure adequate device performance during its entire shelf-life?, Stability studies
 What should be supported and validated by real-time shelf life testing?, accelerated shelf life testing
 What is the usefulness of predicting an expiration date from accelerated stability studies unclear?, because there is no validated accelerated testing method and because of the nature of adhesives and conductive gels
 What should also include information that demonstrates the role of accelerated stability testing in predicting the expiration date?, accelerated shelf-life testing
 What are the two main reasons for using reusable ECG electrodes?, potential for skin reactions and disease transmission
 What is the main benefit of disposable ECG electrodes?, they are intended
 What must an investigational plan also include in order to be considered?, a description of the device and its important components
 What is the name of the non-critical areas of the body that ECG electrodes are used on?," clean, intact skin"
 What is the regulated under 21 CFR 882.1275?, Electroconductive media
 What must the electrode lead wires and patient cables be in compliance with?, test requirements and test methods
 What is the name of the document that describes ECG cables and leadwires?, ANSI/AAMI EC53
" What must be MRI compliant, X-ray translucent, and MRI compliant before a medical device is introduced into interstate commerce?", 21 CFR Part 801
 What does 801 Subpart C require for final labeling for an over the counter device?, labeling recommendations
 What should the intended use also identify?, the duration and application of use
 What should only be used by or in consultation with a health care provider familiar with their proper placement and use?, ECG electrodes
 What should be replaced if self-adhesive electrodes no longer stick firmly to the skin?, Self-adhesive electrodes
 What is the labeling for devices that contain natural rubber latex?, 21 CFR 801.437
 What should be included in each planned clinical study?," a detailed description of the initial feasibility study (i.e., study to define clinical metrics or device design)"
 What specifies the limitations to exemption?, Section 21 CFR 870.9
 When was the Draft Guidance on Medical Device Patient Labeling issued?," March 3, 2000"
 What is the name of the room that is used to submit comments to the agency?, Room 1061
 Where can you obtain additional copies of guidance?, the Internet
 What are the general types of information that may be included in medical device patient labeling?, types of information that may be included in medical device patient labeling
 What is the purpose of Appendix D?, Appearance of graphics: ..35 Appendix D Warnings and precautions: 39 Appendix F Pretesting: 44 Checklist Summary: ..46 References: Answer: 46 References: Answer: 44 References: Answer: 44 References: Answer: 44 References: Answer: 44 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer:
 What is the total time planned for subject follow-up?, time planned for subject follow-up
 What does not create or confer any rights for or on any person?, any rights
 What is the purpose of this guidance?, to assist manufacturers in their development
 What does Device labeling evolve throughout?, the review process
 What is the name of the format in which medical device patient labeling is supplied?, pat
 What is the purpose of medical device patient labeling?," may accompany devices intended solely for physicians to operate, devices for both physicians and patients or lay caregivers to operate, and devices operated solely by patients or their lay caregivers"
 What does patient labeling inform patients or their lay caregivers about?," proper use, risks, and benefits of the device"
 What is needed to make devices safe and effective?, Adequate directions for operating the devices
 What is the term for information that allows the users to become aware of potential problems with the device?, Risk/benefit information
 What is the main risk to the patient associated with using a device?, environment
 What is the “how to” for a device?, Instructions for Use
 What are the primary safety and effectiveness endpoints described as?, specific objective clinical targets
 What is the name of the device that is used to physical therapy equipment?, transdermal electrical nerve stimulation (TENS) devices
 What type of users are more likely to use the device as you intend?, Knowledgeable
 What is a risk/benefit information situation?, instructions for use
 What should lay caregivers need to do to explain the operation of the device to others?, explain the operation of the device
 What should lay caregivers or others need to understand to use a device?, requirements of care or the alterations of lifestyle associated with care
" What are some examples of ways that patients or lay caregivers can cooperate with the prevention, treatment, or diagnosis of an illness?"," bone density scan, drugs of abuse test kits"
 What is a tool of the health care practitioner and the patient is not involved in the choice of the device?, The device is a tool of the health care practitioner and the patient has no control over or access to the device
 What is a patient's opportunity to benefit from patient labeling outweighed by the risk of allowing him the opportunity in an emergency?, the risk
" What is the patient's right to know, choose, and decide subordinated to?", obligation to give prudent care
 What is the minimum time a health professional or supplier must pass along the patient labeling?," Must an intermediary, such as a health professional or a supplier, pass along the patient labeling or can it be provided directly to the patient"
 What are medical image analyzers required to comply with under 21 CFR 892.2070?, special controls
 What is the primary safety endpoint?, primary
 What can you do to help patients get the most up-to-date information?, place patient labeling there
 What is the name of the document that FDA released that detailed the requirements for patient labeling?, Draft Report on Medical Device Labeling: Patients’ and Lay Caregivers
 What is grouped together?, similar information
 What might not apply to all medical device labeling?, headings related to instructions for use
 What is a good place to place a glossary if the medical device labeling is lengthy and complex?, after the table of contents
 What is the purpose of the device?, Briefly describe the FDA cleared or approved indications for use
 What are conditions under which a device should not be used because the risk of use clearly outweighs any possible benefit?, Contraindications
 What are known and reasonably foreseeable hazards?," List known and reasonably foreseeable hazards, not theoretical possibilities"
 What is the risk of being harmed because of patient characteristics?, substantial risk
 What is the goal of risk/benefit information as applied to medical device patient labeling?, to provide the patient with information about the risks and benefits associated with a device or procedure in a manner that is meaningful to the user
 What should be clearly delineated in the study protocol?, reporting and adjudicating adverse events
 What should people's concerns about their personal risk be addressed?, Anticipate and respond to people’s concerns
 What can be done to overcome risk?," take the silicone sheet off for a few days, then start again"
 What can help to ensure more accurate interpretation of risk information?, Combining visuals with brief text that contains the “take-home” message
 What should the content of risk messages reflect?," the perspective, technical capacity, and concerns of the target audience"
 What does “risk” raise?, alarm
 What should be limited to when making comparisons?, risks that are similar or closely related
 What is the purpose of nalogies?, • may discuss the nature of the risk. • may include alternatives. • may discuss benefits.
 What is the attitude toward the risks and benefits?, What is the attitude toward the risks and benefits
 What is Embedded in the concept of risk/benefit information?, the type of in Appendix E
 What is the specific hazard alert information that a user needs to know before using the device?, general warnings and precautions
 What should the benefit-risk framework focus on?, device technology
 What do warnings and precautions tell the reader about?," hazards, other than those"
 What provides information on how to avoid hazards?, Warnings and precautions
 What can that approach lead to?, information overload
 What is the eighth grade reading level?, ps
 What is the name of the step that should be followed for setup?, table top or floor
 What is a good example of a checkout procedure?, visual inspection of the device
 When should the checkout be done?, at the time of setup and/or before each use
 What should the user place immediately before the corresponding task or instruction?, any warnings or safety instructions
 What does the section in the medical device patient labeling explain to the user?, the importance of monitoring the activity of the device
 What is the name of the device that is used to clean?, device
 What is the only subset of the eligible study subject population allowed to accept?, the risks as weighed against the benefits
 What should the user briefly outline to help them with maintenance?," proper maintenance actions, who is responsible, and how often the action should be done"
 What should the user do if extended storage may affect the device?, inform the user
 What is the expected failure time and mode and its effect on the patient?, State how long the device will last
 What is an example of a device that can be safely disposed of?, mercury containing devices
 What is the purpose of the additional device?, impacts the safe and effect
 What does troubleshooting help determine when a problem occurs?, if the problem is with the device or with the patient’s condition
 What is the name of the section that highlights each group heading?, Highlighting
 What should users do if their device displays error messages?, list them and what they mean
 What is the name of the section that tells the user how to report undesirable outcomes?, adverse events
 What do we refer to the categories of information that not all patients want in medical device labeling?, additional information
 What are some patients more risk averse?, some patients
 What is the most common way to have additional information available on demand?, most prefer to see it at the end of the document or have it available on demand
 What type of information should a patient have to have to be written in?," simple, plain language"
 What may have adverse event data from other sources?," Other devices may have adverse event data from other sources, e.g., published literature or experience with similar devices"
 What is the name of the section that contains potentially fatal adverse events?, Contraindications section
 What is the name of the device that a patient can use to list their implant?, card or sticker
 What is the name of the converter that may need to convert to the proper voltage?, converter
 What does the FDA recommend for all other devices?, labeling
 What can include a toll-free number or the number for customer assistance?, medical device patient labeling
 What is readability defined as?, the style of writing
 What is the quantitative factor used to assess readability?, results of readability formulas
 What may disapprove an IDE application if there is reason to believe that the risks to the subjects outweigh the anticipated benefits to the subjects and the importance of the knowledge to be gained?, FDA may disapprove an IDE application if there is reason to believe that the risks to the subjects outweigh the anticipated benefits to the subjects and the importance of the knowledge to be gained.
 What is the purpose of repeating important points and summarizing important information?, increase the reader’s recall and reading comprehension
 What is the reading level of the medical device patient labeling?, eighth- grade level
 What should be rewritten by applying the 23 principles of writing for increased comprehension?, patient labeling
 What is holding a lighted match under a thermometer when you want to make your house warmer?, shortening words and sentences
" What helps to find places where the medical device patient labeling may be inaccurate, incomprehensible, or poorly organized. User- oriented testing?",
 What are context clues?, words that surround a particular word or passage and can throw light on its meaning
 What are the general principles of writing for increased comprehension?, Write with a specific type of person in mind. Stress the “need to know” information
 Who will be using the device?," elderly, disabled, or children"
" What is one approach to provide a well-segmented, highlighted document with a table of contents and the most-desired, basic information up front?"," provide one well-segmented, highlighted document"
 What is the intermediate form called?, a mini manual
 What is the name of the Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications?, Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
 What is the term for a word that may affect the device and cause rust?, Dampness
 What is the best way to store a device?, Always store the device in a dry area
 What is the tolerance level of the gauge?, 65 mm
 What is the second person to personalize the material by using instead of the third person?," “he,” “she,” or “they.”"
 What is the better adverb?, green wire
 What is necessary when operating the device?, Avoidance of cellular phones
 What is the abbreviation for oxygen instead of O 2?, oxygen
 What is the worst thing to do when using a device?, Look at the power cord for cuts or frays
 What should you avoid in a sentence?, formal language
 What do parentheses cause?," the reader to hesitate, making it hard to read"
 What does FDA staff determine about the probable benefits of the device?, whether the probable benefits of the device outweigh its probable risks
 What should be the main idea of paragraphs?, a simple topic sentence
 What should a reader do to avoid missing steps?, tell the reader how many steps are in the procedure
 What do people most readily identify Arabic numbers with?, steps in a sequence
 What is the better part of the procedure?, To turn the machine on: 1. Plug the power cord into an AC outlet
 What is the purpose of cross referencing?, It is confusing to the reader
 What is the speed by which letters and words can be recognized?, legibility
 What is the most important part of a text heading?, capture the main points
 What font allows more variation among letters than sans serif?, serif
 What is the main purpose of using highlighting techniques?," to emphasize important words, thoughts, or phrases"
 What should be used between blocks of text to aid the ease of reading?,
 What should be used ragged right margins?, Use ragged right margins
 What is a significant factor to consider?, neurological device
 What is normally not appropriate and their use should be minimized in instruction manuals?, tables
 What type of art makes the text more meaningful?, Illustrations
 What do circles or arrows do to point out key information?, point out key information
 What should be the title of a text?, Figure 1
 What should be Eliminate 37 detail that is not necessary?, Captions
 What should be included if a table or graph is necessary?, instructions on its use
 What does this section discuss?, their use in medical device labeling
 What is the least preferable method of controlling accidents and injuries?, Labeling
 What does the term warnings and precautions present the reader with a cue to?, the seriousness of the hazard
 What is the signal word for a hazard alert?, WARNING
 What is an essential part of FDA's evaluation of devices targeting neurological disease progression?, Assessing probable benefits and probable risks
 What is the target audience for medical device labeling?, target audience
 What is the hierarchy of hazard alerts?,39
 What must readers believe they can perform to avoid the hazard?, recommended response
 What is the name of the symbol used to warn a reader of important hazard information?, CAUTION
 What is the objective of this directive?, to give clear instructions to the user on how to avoid the hazard
 What has shown that Hazard alert has a significant effect on readers?, Hazard alert research
 What must a writer apply to write effective warnings and precautions?, principles discussed here
 What may a home use device have warnings and precautions grouped according to?," Setup, Calibration, Use, Storage, and Disposal"
 What should warnings and precautions be in order of?, clinical significance
 What do users more likely to read and comply with with warnings or precautions presented in outline form using plenty of?, plenty of white space and consistent indentations
 What must the test dataset contain?, a sufficient number of cases from important cohorts
 What provide potential participants adequate information to consider when deciding whether or not to participate?, Informed consent documents
 What is the use of white space and simple high?, Conspicuous
 What can increase consumer recognition?, Standardizing terms and formatting across the labeling
 What is the reason for placing warnings and precautions in separate sections of medical device labeling?, user familiarity with this format
 What is the most effective location relative to relevant text?, placement immediately before the associated procedural task
 What is the most effective way to get readers to notice and read warnings and precautions?, testing draft warnings and precautions
 What can have the same diluting effect as over-warning?, Careless designation
 Why should you not rely on readability indexes to predict warning and precaution comprehension?, complexity of the process by which individuals interact
 What is the most effective presentation for the intended audience?, labeling
 What is the main method of pretesting the medical device labeling?," individual in-depth interviews, focus group interviews, self-administered questionnaires, usability testing, and readability testing"
" What helps to find places where the patient labeling may be inaccurate, incomprehensible, or poorly organized?", User-oriented testing
 What does FD&C stand for?," Federal Food, Drug, and Cosmetic Act"
 Who guides the discussion?, a skilled moderator
 What is an important sub-component of usability considerations for medical devices?, patient labeling
 What is the purpose of usability testing?, the use of the device and its labeling materials by a group of intended users of the device
 What can be used to assist the process of reviewing patient labeling?, Usability test results
 What is the importance of a care regimen?, Importance of the need to adhere to a care regimen
 What is the purpose of the guidance on the labeling of a medical device?, Writing for increased comprehension
 What is the name of the publication that published the chapter 5 of Communicating Risks to the Public?, Kluwer Academic Publishers
 What must an informed consent document for a neurological device targeting the progression of a disease describe?," the possibility that the proposed treatment may have little or no effect upon halting or delaying the progression of the disease, or could increase rate of progression"
 What is the labeling required to comply with?, 21 CFR 812.5
 What should your labeling alert users to?, potentiall
 What is IDE?, Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
 When was the draft of the FDA/HCFA Interagency Agreement issued?," June 1, 2016"
 What is the name of the agency that regulates devices for Biologics Evaluation and Research?, Center for Biologics Evaluation and Research
 What is the address of the Dockets Management Staff?, Food and Drug Administration
 What is the name of the office that provides CBER guidance?," Office of Communication, Outreach, and Development"
 What are the recommendations that follow useful in demonstrating?, compliance with those special controls
 What is the name of the document that contains nonbinding Recommendations?, 2 Contains Nonbinding Recommendations Table of Contents I. Introduction . 4 II. Background . 5 III. FDA Interpretation of Medicare Coverage Categories A and B . 8 IV. Considerations When Changing from Category A to B .. 9 V. Examples ... 11 VI. Conclusions
 What is IDE?, Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
 What does IDE stand for?, investigational device exemption
" What did the FDA's Center for Devices and Radiological Health execute on December 2, 2015?", a Memorandum of Understanding
 What did the MOU note the need for FDA and CMS to do?, revise their shared understanding
 When did the MOU take effect?," June 2, 2016"
 What is the second category that FDA would assist CMS in identifying?, Non-experimental/Investigational (Category B) dev
 What did the IA set forth that FDA would use to categorize devices?, criteria
 What were devices believed to be in class III for which “absolute risk” of the device type had not yet been established?, Category A devices
 What is a Category A device?, those devices for which no marketing application had been approved through the premarket approval (PMA) process for any indication for use
 What is the purpose of the recommendations in this document?, guide you as you develop and test your CADe device
" What was the name of the IDE Guidance Memorandum that was issued on Sept. 15, 1995?", #D95-2
 What was the primary risk in question for devices believed to be in Class I or II?, incremental risk
 What were Category B devices under investigation to demonstrate substantial equivalence to?, a predicate device
 What is Category B?, Category A
 What is the FDA unsure of?, whether the device type can be safe and effective
 What is a factor in evaluating whether or not an IDE device receives Medicare coverage?, CMS uses FDA’s categorization determination
 What is the criteria for a Category A device?, 42 CFR 405.212
 What does 42 CFR 405.211(b) do?," Contains Nonbinding Recommendations Category A (Experimental) IDE study, but not the device itself"
 What is the name of the document that provides guidance on the development and review of IDE applications for early feasibility studies?, IDEs
 What are feasibility studies intended to provide?, proof of principle and initial clinical study data
 What is the most common submission type for CADe devices addressed in this guidance?, A 510(k) submission
 What are clinical investigations designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use?, Pivotal studies
 What is the category designation based on?, the criteria described in this document
 What did the IA not describe?, a pathway for chang
 What did CMS change in January of 2015?, 42 CFR 405.211(a)
 What did CMS and FDA need to revisit to ensure reimbursement of devices will not be precluded due to an inappropriate reimbursement categorization determination?, their shared understanding
 What is the definition of an IDE application?, approved with conditions
 What is the FDA unsure if the device type can be safe and effective?, whether the device type can be safe and effective
 What is being studied for a new indication?, The proposed device
 What is the FDA Guidance document called?, FDA Decisions for Investigational Device Exemption Clinical Investigations
 What does the FD&C Act stand for?," Food, Drug, and Cosmetic Act"
 What does the proposed device have different compared to a legally marketed device?, technological characteristics
 What is the primary risk in question for a device?, the incremental risk
 What resolves the initial questions of safety and effectiveness?," available information (e.g., feasibility study data) from the proposed device or a similar device"
 What may also have been used to resolve these questions?, additional non-clinical and/or clinical data
 What can come from different sources and become available at different points in time?, Data
 What is the name of the stage of a clinical study on the investigational device?, a stage of a clinical study
 What may be warranted when an IDE study receives a staged approval?, category change
 What may resolve initial questions of safety and effectiveness?, data gathered from the first (or subsequent) enrollment stage(s)
 What is a categorization decision made upon study approval?, a new study
 What should the supplement include that would support meeting the criteria as identified in 42 CFR 405.201(b)?, data which would support a change from Category A to Category B
 What is a complex relationship between the CADe output and the clinician such that clinical performance may depend on a variety of factors that should be considered in any study design?,  timing of CA Answer:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing of CA:  timing
 What is included as supportive information?, Additional non-clinical data on the same or a similar device
 What may also change from B to A?, category designation
 What is the name of the document that the sponsor must send to CMS to determine the categorization decision?, IDE (original or supplement) approval letter
 What is the definition of Category A?," completely novel and has no, or limited, previous human use"
 What is not available to address the initial questions of safety and effectiveness associated with the addition of the drug?, relevant non-clinical or clinical data
 What is the device’s technology unchanged from?, what was initially approved or cleared
 What is the initial question that FDA is unsure whether or not the device type can be safe and effective?, effectiveness
 What is inadequate 11 Contains Nonbinding Recommendations evidence to resolve initial questions related to safety because this will require follow up in a clinical study?,
 What did the non-clinical test data resolve?, initial questions of safety and effectiveness related to this change
 What will be studied for an indication for which substantial safety and effectiveness information exists from other similar device(s) of the same type that are used for the same?, A new device
 What is the name of the FDA's room 1061?, HFA-305
 What should be used to preclude or limit biases that might impact conclusions?, well-controlled study design
 What is the purpose of the st Answer: A modification has been made to an approved device in order to improve its performance?,
 What has been resolved based on experience with the approved device?, safety and effectiveness
 What resolved initial questions of safety and effectiveness for the new patient population?, Non-clinical and clinical data
 What may be appropriate to change the Category from A to B?," If the device was previously designated as Category A, but the initial questions of safety and effectiveness of the device have since been resolved"
 What is the name of the procedure that is used to place an already-approved or -cleared device?, novel insertion procedure
 What is the second stage of a staged clinical study called?, Category B
 What is needed to help inform a pivotal study design?, Additional data
 What is the process of categorization of IDE devices?, whether available data demonstrate that initial questions of safety and effectiveness have been resolved
 What is the categorization of IDE devices used by CMS?, as part of its determination of which devices meet the requirements for Medicare coverage
 What is the name of the category decision Flowchart?, Category Decision Flowchart
 What is the most difficult to duplicate in the laboratory setting?, clinical environment in the laboratory
 What is the name of the docket that is listed in the notice of availability?, HFA-305
" What is the name of the U.S. Department of Health and Human Services Office of Communication, Outreach and Development?", CBER
 What is the name of the office that is responsible for the evaluation and research of biologics?," Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002"
 What is the name of the center that studies radiological health?, Center for Devices and Radiological Health
 When is OCP released?, September 2023
 What is the name of the example of a PRESCRIPTION DRUG USE-RELATED SOFTWARE FUNCTIONS and END-USER OUTPUT?, APPENDIX A
 What is the name of the document that contains nonbinding Recommendations Draft?, Nonbinding Recommendations Draft
 What does not establish any rights for any person and is not binding on FDA or the public?, It does not establish any rights
 What is the name of the center that is responsible for the development of the software outputs?, Center for Biologics Evaluation and Research
 What is the name of the organization that created the guidance?," Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) at the Food and Drug Administration"
 What is the FDA's guidance entitled?, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submi Answer: The Q-Submi Answer: The Q-Submi Answer: The Q-Submi Answer: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The
 What does the term sponsor refer to?, sponsors and applicants
 What is the primary mode of action of a drug?, the drug provides the greater contribution to the intended therapeutic effects
 What is the term promotional labeling generally used to describe?, any labeling other than FDA-required labeling
 What is the FDA's drug labeling authority called?, Prescribing Information
 What does this guidance not apply to?, software developers
 What does the FD&C Act define labeling as?," all labels and other written, printed, or graphic matter"
 What did the Court consider in evaluating whether materials “accompany” a product?, whether the drug product and the materials related to the drug product were part of an integrated distribution program
 What does CDRH stand for?, Center for 63 Devices and Radiological Health
 What does FD&C stand for?," Federal Food, Drug, and Cosmetic Act"
 What is another option for the clinical performance assessment of some CADe devices?, A stress test
 What is the FDA anticipating a significant proportion of?, prescription drug use-related software functions
 What is a function that is subject to FDA drug labeling authorities?, some of these software 79 functions may meet the definition of a device11 as defined in the FD&C Act and would be 80 subject to device requirements
 What do guidances describe the Agency's current thinking on a topic?, the Agency’s current thinking
 What is the CDRH Digital Health Center of Excellence?, empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation
 What does the term device not include?, software functions
 What is the form FDA 2253?, Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
 What is one of the uses of software?, assisting patients with tracking their own drug ingestion
 What does FDA intend to do when it comes to drug labeling?," implement its policies and exercise its authorities, including drug labeling authorities"
" What is the labeling that is reviewed and approved by FDA as part of an NDA, 115 ANDA, or BLA, as well as supplemental applications?",
 What must be truthful and non-misleading?, Promotional labeling
 What will likely alter reader performance in the trial compared with clinical practice?, the use of sample enrichment
 What is the postmarketing reporting requirement for submitting promotional materials to FDA?, postmarketing reporting requirements
" What is a 132 output that supplements, explains, or is otherwise textually related to one or more of the 136 sponsor’s drug products?", end-user 135 output
 What is one factor FDA intends to analyze when a sponsor 137 proposes to disseminate prescription drug use-related software for use with a drug or 138 combination product?," whether the end-user 139 output should be treated as FDA-required labeling or promotional labeling and how, or if, the 140 corresponding software function should be described in the PI"
 What is provided to support a clinical benefit when the prescription drug use-related software is used?, evidence
 What is the software function18?, prescription drug use-related software
 What rely on data directly19?, device-connected software functions
 What does the guidance for industry and FDA staff describe?, Multiple Function Device Products: Policy and Considerations
 What is the end-user output 167 of a software product considered to be?," screen displays created by the software, whether static or dynamic, 168 as well as sounds or audio messages created by the software"
 What should Sponsors provide to support how the combination product used with the software will not lead to medication errors?," medication errors, such as inappropriate administration of extra doses"
 What must the PI contain?, a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The
 What is the design that can be “fully-crossed”?, MRMC design
 What is the effective use of the drug product?,190
 What is the name of the software that accompanies the proposed generic product?, prescription drug use-related software
 What is the name of the section that describes the FD&C Act?, section 505(j)(2)(A)(v)
 What is a nonbinding recommendation Draft?, Not for Implementation 195 products
 What is the PI supposed to describe?, device-connected software
 What should a sponsor provide that 207 demonstrate that use of the prescription drug use-related software results in?, a meaningful 208 improvemen
 What should be consistent with the general approach used for evaluation of PI content?, FDA’s assessment of the prescription drug use-related software-related information
 What does the placement and extent of information describing 217 software functions in the PI depend on?, the evidence submitted by the sponsor and whether the 218 software functions are device-connected
 What may demonstrate that a combination product 229 with device-connected prescription results in a meaningful improvement in a clinical outcome?, evidence
 What is a dose-tracking app?, a meaningful change in a clinical outcome or validated surrogate endpoint
 What is an acceptable non-fully crossed study design?, non-fully crossed study designs
 What should be reviewed and approved by FDA as is required for 24 See 21 CFR 314.126(b)?,
" What is the following 255 Answer: In many cases, a sponsor may develop prescription drug use-related software that relies on data 252 directly transferred from the device constituent part of a drug sponsor’s combination product without generating evidence showing that use of the prescription drug use-related software 254 confers additional clinical benefit beyond that of the combination product alone.?",
 What is a sponsor's proposal to include in the PI about the inhaler's ability to track inhaler events?, a brief 261 description
 What is a sponsor 266 responsible for?, develop an autoinjector that captures when the autoinjector is used and transfers that 267 information to a mobile app
 What does the prescription drug use-related software relies on in these examples?, data directly 272 transferred from the device constituent part of the combination product
 What should the PI provide in 277?, a brief description 278 of the device constituent part and the associated software function(s)
 What may be submitted in an annual report if the information is consistent with 21 CFR 314.70(d)(2).?,
 What would the end-user output from prescription drug use-related software generally be considered?, promotional labeling
 What must be submitted to FDA by the applicant at the time of initial dissemination?, Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling 296 for Drugs and Biologics for Human Use)
 What is the voluntary opportunity to submit promotional communications to FDA?, 21 CFR 202.1(j)(4)
 What is a key factor for obtaining consistent and convincing scientific evidence?, specification of the statistical analysis
 Who will CDRH consult with regarding the representations about the drug within the prescription drug use-related software?, CDER or CBER
 What must applicants submit at the time of initial dissemination?, Form FDA 2253
 What is the case of cleared devices?, could significantly affect the safety or effectiveness of the device
 What is the requirement for a new or modified device constituent part or component of a combination product?, a new or modified device constituent part or component of a combination product
 What does Example A's network-connected mobile app display on a screen via the mobile app?, data 325
 What is the data showing over time displayed on?, ingestion over time
 What are the five software functions considered?, device-connected software functions 340
 What is the end-user output of the web-application?, display of ingestion data
 What does the Example B mobile app transfer the self-reported information to?, a cloud-based application for their health 354 care practitioner to review on a web-application
 What is the name of the software function that allows the display of symptom 360 incidence and severity data via the mobile app display screen?, software
 What is the rating scale used for?," Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: the selected case sample size, o statistical and clinical justification of the selected number of readers"
 What is the end-user output of the web-application?, display of self-reported information
 What is the example C intended to be used with?, a combination product
 What does the 380 patient mobile app transfer the self-reported 382 data to?, the health care practitioner web-application
 What is the web-application used to aggregate?, self- 384 reported symptoms data and the data collected from the device constituent part of the 385 combination product
 What is the transfer of notifications and alerts to a health care 394 practitioner web-application?, the transfer of notifications and alerts
 What is the transfer of patient- 398 self reported data to the health care practitioner web-application?, transfer of patient- 398 self reported data
 What are the four end-user outputs?, the web-application’s display of data
 What is the patient mobile app's display of data collected from the device constituent part of the combination 414 product?, patient mobile 413 app
 What is the software included in the mobile app?, dose calculator function
 What is the output determined to be for the prescription drug?, promotional labeling
 What is the details of the scoring technique used?, Section IV.E. Scoring
 What does the changes do that do not affect the clinical use of the device?, do 435 not affect the clinical use of the device
 What does the mobile app mention?, sponsor’s drug name
 What does the welcome video include information on?, the safety and effectiveness of the 447 insulin product but does not provide information on the dose calculator
 What is the most recent version of a guidance?, FDA guidance web page
 What must be submitted on Form FDA 2253 at the time of 452 initial dissemination?, revised output
 What is the name of the end user that the prescription drug use-related software presents to the end user?," a patient, caregiver, or health care practitioner"
 What does software function 468 rely on?, data directly transferred from the device constituent part of a sponsor’s combination 469 product
 What is the name of the document that provides guidance for industry and Food and Drug Administration Staff?, Guidance for Industry and Food and Drug Administration Staff Document
 What is the docket number of FDA-2018-D-1774?, FDA-2018-D-1774
 What is the document number of the guidance?,16016
 What is the name of the study that is the subject of the book?, Evaluation Paradigm and Study Endpoints
 What is appropriately representative of the intended use population?, study populations
 What does the guidance not establish any rights for?, any pers
 What is the purpose of this guidance document?, to provide recommendations for information to Answer: The purpose of this guidance document is to provide recommendations for information to Answer: Answer: This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature
 What is the name of the premarket notification submission that is submitted in the labeling of a device?, 510(k)s
 What is the name of the coating that devices often have to reduce friction between devices?," polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone"
 What are hydrophilic and hydrophobic coated devices used for?, more than 20 yea
 What does the FDA believe may separate from intravascular devices in some circumstances?, coating
 What is the name of the document that describes the separation of hydrophilic and/or hydrophobic coatings from medical devices?, Medical Device Reports
 What has the FDA evaluated in relation to ducers?," peer-reviewed medical literature1,2,3,4 and physician surveys"
 What did some patients require to mitigate the consequences of coating fragments?, surgical intervention
 What is the purpose of the communication?, to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate from medical devices
 What is the purpose of study endpoints?, to demonstrate that your CADe device is effective
 What was the name of the device used to treat supraclinoid aneurysms?, Pipeline Embolization Device
" What is the Human Pathology, 2015?", 46(3): 488-489
 What is the FDA not suggesting is associated with higher risks than others?, any specific manufacturer or brand of these devices
 What is the FDA guidance titled?, Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests
 What is the name of the guidance document that provides labeling recommendations for intravascular catheters and wires?, Labeling recommendations for both Class III and Class II devices
 What are the devices in the scope of this guidance?, a variety of devices and product codes
 What is the Regulation Number of the DQO Catheter?," Regulation Number DQO Catheter, Intravascular, Diagnostic"
 What is the term for the Term Greater Than 30 Days LJT Port & Catheter?, Term
 What is the current product code of the device for Acute Ischemic Stroke Treatment?,870.133
 What is the receiver operating characteristic (FROC) curve?, free-response receiver operating characteristic (FROC) curve
 What is the name of the table that shows the classification of Class III devices?, Table 2
 What is PTCA?, nal Coronary Angioplasty
 What are the recommendations based on?, known safety issues
 What is the name of the FDA guidance on deciding when to submit a 510(k) for a change to an existing device?," “Deciding When to Submit a 510(k) for a Change to an Existing Device,”9"
 What should the device description prominently note the presence of?, the coating
 What should all indications for use described in the labeling be supported by?, information in the premarket submission
" What are many devices designed, labeled, and indicated for?", specific uses
 What is the name of the document that should be included in the labeling of a device?, precaution statement
 What should include information that will guide the user in a clinical setting?, The preparation steps
 What should you include if you believe one or more of the considerations are not applicable to your device?, any additional warnings and precautions not identified below that you determine are necessary to promote the safe use of the device based on your device design and intended use
 What is the LROC curve?, sensitivity (Se) and specificity (Sp)
 What is a warning against reuse or re-sterilization of the device?, reuse or re-sterilization of the device
 What is the recommended duration for pre-conditioning?, appropriate duration
 What should a user do if they have a known incompatibility with specific media or solvents?, specification of any known incompatibility
 What should the labeling instruct and warn users to do?," use caution when manipulating, advancing and/or withdrawing these devices"
 What may result in adverse events (section D below) requiring additional intervention?, coating material remaining in the vasculature
 What is important to the user to be informed of?, key device dimensions
 What is the term for aqueous media in which a coating swells?, saline
 What should be presented in a format consistent with 21 CFR 801.18?, The date
 What should be avoided during preparation or device use that could result in misuse scenarios or coating damage be identified?, Any practices that should be avoided during preparation or device use
 What should the labeling instruct the user of?, appropriate shape configurations and shaping
 What is the probability that a test is negative for a population of normal patients?, Sp
 What should the user do if the device should not move freely?, exercise caution when removing the device and/or other components as a unit
 What may depend on the specific design?, specific adverse events
 What are some of the adverse events that may occur at the access site?,  Sterile inflammation or granulomas
 When was the original document issued?," September 25, 2013"
 What is the name of the facility that Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research is located in?, U.S. Department of Health and Human Services
 What is the OCOD?," Office of Communication, Outreach, and Development"
 What does FDA intend to exercise for software functions?, enforcement discretion
 What does the guidance not establish any rights for?, any person
 What is the FDA's goal in educating manufacturers and distributors about software functions intended for use on mobile platf?," to inform manufacturers, distributors, and other entities"
 What is a software function that meets the definition of a device deployed on?, a “mobile medical app.”
 What can be done simultaneously within a single reader study?," Data collection for ROC, Se, and Sp"
 What is the FDA website on?, Software as a Medical Device (SaMD)
 What does the FD&C act not regulate software functions as?, devices
 What does FDA consider the functionality of rather than platform?, software
 What was the guidance minorly updated in accordance with?, changes described in the guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.”
 What is the final rule titled?, Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
 What is the FDA guidance titled?,Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
 What is the name of the law that regulates medical software?, 86 FR 20278
 What is the name of the FDA's guidance documents?, Nonbinding Recommendations Devices
 What are innovators trying to leverage to increase portability?, mobile platforms can offer
 What did the use of computer and software products as medical devices grow exponentially after 1989?, use of computer and software products as medical devices
 What is the name of the book that Chapman & Hall published in 1991?, Practical Statistics for Medical Research
 What does the Agency identify through classification?, specific regulatory requirements that apply to these devices and their manufacturers
 What does FDA use the term health care professional to mean?," an individual who is licensed, registered, or certified"
 What is the name of the allied health professional?," nurse practitioner, registered nurse, licensed practical nurse, clinical social worker"
 What has FDA previously clarified when a software application is used to analyze medical device data?, when a software application is used to analyze medical device data
 What can pose potential risks to public health?, certain software functions that are device functions
 What did the Cures Act remove from the definition of device?, certain software functions
 What does this guidance clarify and outlines?, FDA’s current thinking
 What is the FDA's guidance on Medical Device Accessories?,Medical Device Accessories - Describing Accessories and Classification Pathways
 What is the name of the document that describes the changes in the medical software?, changes-existing- medical-software-policies-resulting-section-3060-21st-century-cures-act
 What are examples of mobile platforms?, mobile computers
 What is the ROC summary performance metric used to assess?, ROC summary performance metric
 What is a web-based software application tailored to a mobile platform but executed on a server?, Mobile Medical Application (Mobile Medical App)
 What is a mobile app intended to be used as?, an accessory to a regulated medical device; or  to transform a mobile platform into a regulated medical device
 What is a device intended for use in the diagnosis of?," disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man"
" What is the purpose of software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud”?", may be subject to device regulation
 What determines whether a mobile app meets the definition of a “device”?, intended use
 What is an example of a mobile app that makes a light emitting diode operate?, section 201(h)
 What is a software function intended for use in performing a medical device function?," diagnosis of disease or other conditions, or the cure, mitigation, treatment"
 What is regulated under 21 CFR 870.2340?, Electrocardiograph
 What is FDA's oversight not determined by?, the platform
" What may be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives?", objective intent
 What may provide additional information for understanding the expected impact of a device on clinical practice?, Reporting Se and Sp (or Se and recall rate)
 What is the name of the person from whom he received the devices?, the person from whom he received the devices
 What does the term ‘labeling’ mean?," all labels and other written, printe"
 What could pose a risk to a patient’s safety if the software applications were to not function as intended?, if the software applications were to not function as intended
 What is a “mobile medical app manufacturer”?, any person or entity that manufactures mobile medical apps in accordance with Answer: Answer: Answer: Answer: Answer: a “mobile medical app manufacturer”
 What is a mobile medical app manufacturer?," anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components"
 What is an example of a mobile medical app manufacturer?," any person or entity that:  Creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a mobile medical app software system from multiple components"
 What is the second party?, individuals or entities (second party)
" What is the process of making a device by chemical, physical, biological, or other procedures?"," making by chemical, physical, biological, or other procedures"
 What is the name of the person who makes final delivery or sale to the ultimate consumer?, the person who makes final delivery or sale to the ultimate consumer
 What is the definition of a creator of the original idea for a mobile medical app?, creators
 What should you check all methods utilized in your analysis for?, the adequacy of their fit to the data
 What would the author be considered?, the manufacturer
" What would none of the persons or entities in these examples have to register their establishments, list their products with FDA,25 or submit a premarket application?", Manufacturers or distributors
 What is the mobile platform treated as when mobile medical apps are run on a mobile platform?, a component of the mobile medical app’s intended use
 What is not regulated by FDA as a medical device?, BrandNamePhone sold to consumers
 What does 21 CFR 803.3 define?, definition of manufacturer
 What does FDA not consider mobile platform manufacturers to be?, medical device manufacturers
 What is the term for providers of general-purpose computer or information technology?, providers
 What is a creator of a mobile medical app or a software system that provides users access to the medical device function through a website subscription?, a mobile medical app or a software system
 What does a licensed practitioner create that enables attaching an ECG el?, XYZ-recorder
 What is not considered a mobile medical app manufacturer if Dr. XYZ is in a telehealth network?, Dr. XYZ is not considered a mobile medical apps manufacturer
 What is the name of the document that contains the potential sources of Bias in a Retrospective Reader Study?, Potential Sources of Bias in a Retrospective Reader Study
 What should not be necessary unless you intend to make specific performance claims?, Powering any additional units-based analyses for statistical significance
 What does the “server software application” provide a service to?, a client software application on a mobile platform
 What does 21 CFR 807.65(d) say?," “practitioners licensed by law to prescribe or administer drugs or devices and who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice.”"
 What may be subject to investigational device exemption regulations?, human subjects
 What does Appendix A provide examples of?, software functions
 What is the Regulatory Approach for Device Software Functions?, V. Regulatory Approach for Device Software Functions
 What is the FDA's approach to overseeing device software functions consistent with?, our existing approach
 What does FDA believe a subset of device software functions poses the same or similar potential risks to the public health as currently regulated devices if they fail to function as intended?, risks
 What must a manufacturer meet to make a device software function?, the requirements associated with the applicable device classification
 What is the focus of FDA's regulatory oversight?, software functions
 What is an extension of one or more medical devices by connecting37 to such device(s) for purposes of controlli?, Software functions
 What is the Recall rate?, the percentage of patients (including diseased and non-diseased patients) that are called back or recalled for additional medical assessment
 What is the criterion for not being physically connected to the regulated medical device?, device software functions or mobile medical apps
 What is a software function that allows a user to control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform?, mobile apps
 What is FDA's guidance document for accessories to medical devices?, “Medical Device Accessories - Describing Accessories and Classification Pathways”39
" What are software functions that use attachments, display screens, sensors, or other similar components required to comply with?", the device classification associated with the transformed platform
 What is an ECG?, electrocardiograph
 What does a software function that displays radiological images for diagnosis transform a mobile platform into?, Medical image management and processing system
 What is a cardiac monitoring software classified as under 21 CFR 870.2300?, cardiac monitoring software
 What is the 21 CFR 884.2740?, perinatal monitoring system
 What is CAD?, image processing software
 What is a software function that analyzes readings from a blood glucose monitor and alerts the user of readings outside a predetermined range?, software function
 What is the name of the 2008 publication that was published by Radiol?, 247(1):12–15
 What does FDA encourage manufacturers of device software functions that perform patient- specific analysis to contact?, FDA
 What does the CDS Guidance say can help users?, 41 21 CFR 892.2050
 What does FDA intend to exercise for software functions that pose a low risk to patients?, enforcement discretion
" What are some software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity?"," o Software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity"
 What is the sole responsibility of the health care professionals who have experience with them in medical applications?, the health care professionals who have experience with them in medical applications
 What does an app use to supplement a verbal description in a consultation between health care professionals?, photos of a patient’s skin lesions or wounds
 What is the software function intended to provide?, a convenient way for clinicians to perform various simple medical calculations taught in medical
 What is the product code NXQ?, medication reminder is a device intended for medical purposes to provide alerts to patients or health care providers for pre-determined medication dosing schedules
 What is the APGAR score?, Glasgow Coma Scale score
 What is the name of the example of software functions for which FDA intends to exercise enforcement discretion?, Appendix B
 What should be clarified and specify a version number if appropriate?, the software implementation
 What is the associated regulation for the device software function?, associated controls
 What is the name of the regulation that regulates the use of medical devices in the 21 CFR?, Quality System (QS)
 What is the name of the nonbinding recommendation for Class III devices?, General Controls
 What is the name of the branch that provides technical training to medical device manufacturers?, MATTB
 What is the name of the Appendix that provides a representative list of software functions that are NOT Medical Devices?, Appendix A
 What does FDA not regulate because these software functions are not considered medical devices?, them
" What is not intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: These are not devices because the software is intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: Answer: The FDA does not consider to be devices because the software is intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: 1. Software functions that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities?",
 What is the use of electronic copies of medical textbooks or literature articles?, Physician’s Desk Reference
 What are not devices because they are not devices?, Software functions
 What is the purpose of software quiz apps?, performing any clinical assessment
 What is the most relevant comparator in CADe performance assessment?, A study control arm that uses conventional clinical interpretation
 What is the purpose of games?, simulate various cardiac arrest scenarios
 What is the purpose of these functions?, supports patient-centered health care
 What does a software function do?," o Help guide patients to ask appropriate questions to their physician relevant to their particular disease, condition, or concern"
 What do patients need to do to help match them with appropriate clinical trials?, o Provide tutorials or training videos
 What does software functions that automate general office operations in a health care setting not intended for use in the diagnosis of disease or other conditions do?, o Determine billing codes
 What does software not provide for hospital emergency rooms?,
 What does software not provide for general-purpose products?, generic aids
 What is a note taking function not intended for the mobile platform?, recording audio
" What is a software function that is intended for individuals to log, record, track, evaluate, or make decisions related to developing or maintaining general fitn?", Software functions
" What do dietary logs, calorie counters, or make dietary suggestions provide?", dietary suggestions
 What is the 21 CFR 886.5540?, Low-vision magnifiers
 What should be appropriate for establishing substantial equivalence?, ntrols or a direct comparison with the predicate CADe device
 What is the name of the game that allows people to track their scores?, mind-challenging games
 What are these software functions meant to enable?, general patient health information management and health recordkeeping activities
" What does the software function that prompts the health care professional to manually enter symptomatic, behavioral, or environmental information do?"," prompt the health care professional to manually enter symptomatic, behavioral, or environmental information"
 What is a software function that allows a user to record data?, collect and log
 What does a software function provide to a health care professional to consider based on a patient’s cholesterol levels and demographics?, a list of appropriate cholesterol-lowering drugs
 What does a software function provide?, easy access to information related to patients’ health conditions or treatments
 What does software match patient-specific medical information to?, reference information routinely used in clinical practice
 What is the software function that enables the health care professional to independently review the basis for the information?, The software function
 What does software function do?, identifies drug-disease interactions and contraindications
 What are these software functions?, software functions that provide patients with tools to organize and record health information without providing recommendations to alter or change a previously prescribed treatment or therapy
 What is the name of the MRMC analysis software that is used in studies that include distinct cases in each arm?, MRMC analysis software
 What is the name of the guidance for information on the criteria relating to this description?, Clinical Decision Support Software
" What is a software function specifically marketed to help patients document, show, or communicate to health care professionals regarding potential medical conditions?", Software functions
 What is a videoconferencing portal specifically intended for?, medical use
 What is the definition of Non-Device-MDDS?," Software functions that are solely intended to transfer, store, convert formats, and display medical device data or results"
 What are multi-patient displays typically used for?, active patient monitoring to enable immediate awareness for potential clinical intervention
" What is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Sto Answer: Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Sto Answer: Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accord with the Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image?",
" What is the name of the document that contains Nonbinding Recommendations findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Nonbinding Recommendations findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer:?",
 What is the definition of Non-Device-MDDS and connect to a nursing central station?, Non-Device-MDDS
 What isplay (but do not analyze or interpret) medical device data to a physician’s mobile platform for review?, Software functions that are not intended for diagnostic image review
 What may these software functions be intended for use in the diagnosis of?, disease or other conditions
 What is the OBUMRM software for?, OBUMRM
 What is another type of software function that helps patients with diagnosed psychiatric conditions?, software functions that pose lower risk to the public
 What is OCD?, obsessive compulsive disorder
 What do software functions that prompt a user to enter which herb and drug they would like to take concurrently provide information about?, whether interactions have been seen in the literature
 What does software use to provide a list of possible medical conditions and advice on when to consult a health care professional?, a checklist of common signs and symptoms
 What are the software functions intended to allow a user to initiate?, a pre-specified nurse call or emergency call using broadband or cellular phone technology
 What does software display trends in?, personal health incidents
 What does software provide for prediabetes patients?, guidance or tools to help them develop better eating habits or increase physical activity
 What does the report based on provide patients and caregivers information about?," drug- drug interactions and relevant safety information (side effects, drug interactions, active ingredient)"
 What poses a risk to a patient’s safety if the software were to not function as intended?, functionality
 What are the software functions that transform a mobile platform into a regulated medical device?, Software functions (typically mobile apps)
 What is the term for a conventional reading by the readers without the CADe device?, reader alone
 What is a software function that uses a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart?, Software functions
 What is the software function that uses a sensor or electrode attached to the mobile platform?," electronically amplify and “project sounds associated with the heart, arteries and veins and other internal organs”"
 What does a sensor attached to the mobile platform do?,
" What does a software function use to record, view, or analyze eye movements for use in the 56 Available at https://www.accessdata.fda.gov/s Answer: 57 Available at https://www.accessdata.fda.gov/s Answer: Answer: 57 Available at https://www.accessdata.fda.gov/s Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer:: Answer:: Answer::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::?",
 What is the software function that uses tools within the mobile platform intended for?, conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders
 What does accelerometer measure?, degree of tremor caused by certain diseases
 What is the LEL code?,882.505
 What is the possible product code for NBW?, 21 CFR 862.1345
 What is a software function that uses a microphone or speaker within a mobile platform to serve as a audiometer to allow health care professionals to determine hearing loss at different frequencies?,
 What are these nonbinding Recommendations oversight?," These software functions are those that control the operation or function (e.g., changes settings) of an implantable or body worn medical device"
 What is the product code for KPR?, 21 CFR 892.1680
" What is the purpose of randomizing readers, cases, and reading scenarios?", reduce bias in performance measures
 What is the focus of FDA's regulatory oversight?, Software functions that are used in active patient monitoring or to analyze patient- specific medical device data
 What is the possible product code(s): LLZ (21 CFR 892.2050)?,
 What is the possible product code(s): LLZ (21 CFR 892.2050)?,
 What is the software function that provides recommendations for FDA-approved treatments based on the findings of the Next Generation Sequencing 28 Contains Nonbinding Recommendations (NGS) Analyzer?, QIC.58
 What does the software function indicate?, whether to transf
 What is the name of the CDS Guidance that describes the examples of Device Software Functions?, Section V.C
 What is the name of the part of 21 CFR Part 807 that requires manufacturers of medical devices to register their establishments62 with FDA?, Establishment Registration and Medical Device Listing
 What is the registration and listing requirement?," a means of keeping FDA advised of who is manufacturing devices, and of the types of devices an establishment is manufacturing"
 What does IDE allow an investigational device to be used in a clinical study?, an IDE
 What is the definition of an Establishment?," “a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.”"
 What is the name of the webpage that provides information regarding the investigational device exemption?, “Device Advice: Investigational Device Exemption.”69
 What does the guidance for Industry and Food and Drug Administration Staff represent?, the current thinking of the Food and Drug Administration (FDA or Agency) on this topic
 How long does it take to separate each reading session in time?, at least four weeks
 What does the QS regulation provide for manufacturers to develop and follow?, a framework
 What is the IDE regulations part 812 of?, IDE regulations
 What is the name of the document that requestsfeedback?, fda-guidance-documents
 What must manufacturers do to ensure safe and effective operation of the device?, appropriately verify and validate their device software functions along with the computing platform
 What does MDR stand for?, Medical Device Reporting
 What must the MDR report contain?, all the information described in 21 CFR 803.52 that is reasonably known to t
 What is the name of the facility that can obtain information about a manufacturer?, user facility
 What is an example of a request that a manufacturer may initiate?, Upgrading software to reduce risk from a “bug” or unintended response
 What is the purpose of a correction to a device?, to reduce a risk to health posed by the device or to remedy
 What is the reporting requirement not extend to?, all modifications to devices
 What must the device manufacturer keep a record of?, correction
 What is Routine servicing defined in?, 21 CFR 806.2(l)
 What is a medical device subject to regulatory oversight?, software function
 What is the phone number for the Division of Industry and Consumer Education?, 301-796- 7100
 What is the name of the FDA's online course that describes regulatory requirements?, CDRH Learn
 Where is the 513(g) process available?, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance
 What is the name of the document that contains nonbinding recommendations?, 513(g)
 What does FDA recommend that manufacturers follow for software that MAY be devices and could be device software functions but for which FDA intends to exercise enforcemen?, Quality System (QS) regulation
 What does FDA believe should be in place to help ensure that their products consistently meet applicable requirements and specifications?, an adequate quality management system
 What are the elements of the QS regulation part of?, FDA’s QS regulation
 What is the scoring process?, scoring process
 What isSWEBOK?, Software Engineering Body of Knowledge
 What does the QS regulation apply to?, medical device hardw
 What is the ISO 9001 Quality management systems – Requirements and ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.?,
 What are some examples of principles within the QS regulation that are relevant to all device manufacturers?," risk assessment and management, design controls, and corrective and preventive actions"
 What is important to the development and manufacture of safe medical devices?, Good design practices
 What is the name of the guidance that A’s issued for Medical Device Manufacturers?, General Principles of Software Validation
 What are the majority of class I devices exempt from?, the premarket submission requirements
 What is the FDA's classification of devices?, Some FDA classifi
 What does a 510(k) exempt mean?," the manufacturer is not required to submit a premarket notification (i.e., a 510(k)) prior to marketing the device"
 What is the webpage that contains additional information about 510(k) exempt devices?, “Medical Device Exemptions 510(k) and GMP Requirements”
 What is the process for determining whether a reader’s interpretation corresponds to the truth status established during the truthing process?," rationale, definition, and criteria"
 What is my app considered?, a mobile medical app
 What are apps from a device manufacturer that provide information to support the company’s own device?, mobile medical apps
 What is not considered on its own to be a device software?, Software used for data collection in clinical studies
 What is the name of the FDA guidance document that contains Nonbinding Recommendations function?, FDA’s guidance related to use of computers
" What is the name of the study that was issued on September 17, 2013?", Electronic Source Data in Clinical Investigations
 What does ANSI stand for?, American National Standards Institute
 What is the ISO 9001 Quality management system?, Requirements
" What is the IEEE Standard for System, Software, and Hardware Verification and Validation?", IEEE Std 1012
 What is the name of the Part 1 of the Guidance on the application of ISO 14971 to medical device software?, IEC/TR 80002-1
 What is the part of the IEC 61508-2 that describes the Functional safety of electrical/electronic/programmable electronic safety-related systems?, Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems
 What should you describe and fix before initiating your evaluation?, the scoring process
 What is the name of the division that provides education about CDRH-regulated devices?, Division of Industry and Consumer Education (DICE)
" What is the address of the Dockets Management Staff, Food and Drug Administration?"," 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852"
 What is the address of the OCOD?," 10903 New Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903"
 What is the address for De Novo Requests?, Address
 What act was passed in 1995?, Paperwork Reduction Act of 1995
 What is the purpose of this document?, to provide guidance on the process for the submission and review of a De Novo classification request
 What does the De Novo classification process provide a pathway to?, class I or class II classification
 What does CBER stand for?, Biologics Evaluation and Research
 What is a device classified in class III and subject to premarket approval?, class III
 What is the risk of a new type of device?, the device and the inability of general and special controls to provide reasonable assurance of the safety and effectiveness of the device
" What is the physical overlap of the boundary, area, or volume of a reader mark in relation to the boundary, area, or volume of reference standard?", physical overlap
 What is the level of risk they pose or the ability of general and special controls to assure safety and effectiveness?, level of risk
 What was the process created by section 513(f)(2) of the FD&C Act referred to as in FDAMA?, Evaluation of Automatic Class III Designation
 What had to be found in order to submit a De Novo request?, not substantiated
 What is a premarket notification?, 510(k)
 What did FDA reclassify devices under?, section 513(e) of the FD&C Act
 What is the name of the nonbinding recommendations currently available informatio?, Nonbinding Recommendations
 What is the name of the subpart that FDA will use to assess whether a request for an evaluation of automatic class III designation is granted?," 21 CFR Part 860, Subpart D--De Novo Classification"
 What is the name of the new section that FDA is updating to reflect the De Novo final rule?," 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff"
 What must the FDA make a classification determination for?, the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must describe the device and detailed information and reasons for any recommended classification
 What is the subject of the De Novo request by written order within 120 days of receipt of the request?, the subject of the De Novo request
 What should you describe when multiple readers are involved in scoring?," the number of readers involved, their qualifications, their levels of experience and expertise"
 What is the device in class III and may not be marketed unless the device i i?, the device i
 What is the definition of a De Novo request?, a new De Novo request
 What will FDA consider a De Novo request for?, devices that have already undergone 510(k) review
 What should appear to meet the statutory standards for classification into class I or class II under section 513(a)(1) of the FD&C Act?, general controls or general and special controls would provide reasonable assurance of the safety and e
 What allows FDA to provide feedback on whether a device may be eligible for the De Novo classification process?, A Pre-Sub
 What is the purpose of a Pre-Sub?," to obtain feedback on the evidence, including non-clinical and/or clinical data, that will likely be necessary to support the De Novo request"
 What is a Pre-Sub?, A Pre-Sub
 What will be handled in accordan?, De Novo Pre-Subs
 What does the FDA search to establish that no legally marketed device and no classification regulation for the same device type exists?, public databases
 What should clinical readers learn about the CADe device?, a description of the device and instructions for how to use the device
 What should the Pre- Sub include in order for us to consider the specific questions?, Specific questions regarding review issues relevant to a planned De Novo request
 What type of evidence do you anticipate providing in your De Novo request?, valid scientific evidence
 What is the proposed mitigation measure(s)/control(s) for each risk based on?, the best available information at the time of the submission
 What is the special use of a device?, mitigations
" What are there other risks, in addition to those identified in the Pre-Sub?", identified in the Pre-Sub
 What would be appropriate if additional biocompatibility and/or sterility testing were needed?, additional biocompatibility and/or sterility testing
 What is the name of the document that describes meetings with FDA staff?, Q-Sub Guidance
 What is the De Novo review process outlined in?, Attachment 1
 What is the name of the website that provides information on vaccines and bloodbiologics?, CBER
 What is the required content for a De Novo request?, 21 CFR 860.220
 What do you justify in your reading instructions?, clinical relevance
 What is the eCopy program for Medical Device Submissions?, eCopy Program for Medical Device Submissions
 What is the current mailing address for De Novo Requests?, current mailing address
 What is the NSE of a device?, general controls or general and special controls may provide reasonable assurance of safety and effectiveness
 What does the inclusion of this language within an NSE letter indicate?," given the risk profile of the device, it seems reasonable that De Novo classification may be appropriate"
 What is the criteria for whether a De Novo request should be reviewed?,11
 What happens if your De Novo request is not accepted for review?, the review clock stops and we will notify you that it is on hold pending receipt of additional information
 What is the deadline for FDA to complete the acceptance review?, 15 days
 What is the purpose of the De Novo classification process?, to analyze whether a likely predicate device exists or your device falls under a class III classification regulation
" What will FDA inform you of in your De Novo request, including each applicable ground for declining the De Novo request?",
 What is the purpose of an AI letter?, If the De Novo request is missing information and/or data necessary to determine whether general controls or general and special controls can provide reasonable assurance of safety and effectiveness
 What does reader training help avoid?, incorrect or un-interpretable results
 What will resume once you provide a complete response?, review
 What is the reason a De Novo request may be declined?, lack of performance data
 What is the name of the section that allows a De Novo request to be granted?, section 515 of the FD&C Act
 What is the classification of class II devices?, special controls
 What is the result of the final order in the Federal Register providing public notice of the decision?," codification of the device’s identification, classification, and applicable requirements in Title 21 of the Code of Federal Regulations"
 What is the name of the website that we intend to make the summary of our review available on?, CDRH website
" What will be redacted to protect any confidential commercial, trade secret, or personal privacy information in accordance with 21 CFR Part 20.?",
 What may the submitter of the declined De Novo request do?, leverage all information in the De Novo request by incorporating it by reference in a new 510(k) submission
 What is the FDA's guidance on De Novo Classification Requests?, FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
 What is the OMB subject to review?, Paperwork Reduction Act of 1995
 What is the name of the FDA Office responsible for this guidance?, Office responsible for this guidance as listed on the title page
 What is permissible for an efficient and less burdensome representative case data set?, Enrichment with diseased/abnormal cases
 What is the FDA's responsibility to the public regarding information collection?, complete and review the information collection
 What is the current expiration date?, 0910-0844
 What is the minimum amount of FDA calendar days to Grant/ Decline FDA Substantive Review Additional information (AI)?, 120 FDA calendar days
 When was the document issued?," September 27, 2023"
" What is the name of the U.S. Department of Health and Human Services Office of Communication, Outreach, and Development (OCOD)?", OCOD
 Where can you find the FDA docket number?," 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852"
 What is the name of the office that provides the Gui00001825?," Office of Communication, Outreach, and Development"
 What is the name of the document that is used to manage cybersecurity risks?, SPDF
 What is the name of the organization that manages the TPLC Security Risk Management?, 19 B. Security Architecture
 What is the name of the appendix that contains the Security Control Categories and Associated Recommendations?, Appendix 1
 What will introduce biases into the study design?, stress testing
 What is the name of the document that is used to submit a Security Architecture Flows submission?, Submission Documentation for Security Architecture Flows
 What does not establish any rights for any person and is not binding on FDA or the public?, It does not establish any rights for any person and is not binding on FDA or the public
 What is the need for robust cybersecurity controls to ensure?, medical device safety and effectiveness
 What may lead to patient harm as a result of clinical hazards?, cyber attacks and exploits
 What does ensuring device safety and effectiveness include?, adequate device cybersecurity
 What is the name of the organization that reviews Regulatory Submissions?, Center for Biologics Evaluation and Research
 What is applicable to devices with cybersecurity considerations?, This guidance document
 What is the name of the application that is used to request Premarket Approval Applications?, PMA supplements
 What is the intended use of the product?," The term ""function"" is a distinct purpose of the product"
 What does this guidance apply to?, devices for which a premarket submission is not required
 What is the study population enriched with?, cases containing small colonic polyps
 What is the benefit-risk threshold for IDE submissions?, different
 What is a shared responsibility among stakeholders throughout the use environment of the medical device system?, medical device cybersecurity
 What has led to potential safety concerns across a broad range of devices?," Vulnerabilities identified in commonly used third-party components, like URGENT/1110 and SweynTooth"
 What is WannaCry Ransomware?, an ever-evolving form of malware designed to encrypt files on a device
 What is the FDA’s Cybersecurity webpage?," https://www.cisa.gov/stopransomware/ransomware-101 10 For more information, see FDA’s Cybersecurity webpage"
 What is the need for capable deployment of mitigations throughout the total product lifecycle?, TPLC
 What is an SPDF?, a set of processes that reduce the number and severity of vulnerabilities in products throughout
 What does QS stand for?, Quality System
 What is the concept of risk management as described in 21 CFR 820.30(g)?, would remain
 What is the name of the FDA rule that would align the device QS with international consensus standards?, 21 CFR Part 820
 What should the sample size of the study be?, large enough such that the study has adequate power to detect with statistical significance your proposed performance claims
 What is ISO 13485?, Medical devices- Quality management systems- Requirements for regulatory purposes
 What is the FDA intends to finalize expeditiously?, proposed rule
 What is the name of the final guidance on Premarket Software Guidance?, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
 What is the definition of a cyber device?, section 524B(a) of the FD&C Act
 What is the purpose of the recommendations in this guidance?, to help manufacturers meet their obligations
 What are the principles in this guidance document important to?, the improvement of device cybersecurity
 What must manufacturers establish and follow to help ensure that their products consistently meet applicable requirements and specifications?, quality systems
 What does section 524B(b)(4) of the FD&C Act require cyber device manufacturers to comply with?, any other such requirements
 What is the premarket context of documentation outputs related to the requirements of the QS regulation?, in order to demonstrate a reasonable assurance of safety and effectiveness for certain devices with cybersecurity risks
 What is the purpose of this guidance?, to explain how such documentation that may be relevant for QS regulation compliance can also be used to show how a sponsor or manufacturer is addressing cybersecurity considerations relevant to a device.
 Powering each cohort for statistical significance should not be necessary unless you are making specific subset performance claims?,
 What does FDA require manufacturers to implement as part of design controls?, development processes that account for and address software risks throughout the design and development process
 What is a SPDF?, Secure Product Development Framework
 What is the FDA's recommendation for quality audits?, 21 CFR 820.22
 What is the definition of servicing?, 21 CFR 820.200
 What is the URL of the website that describes device cybersecurity?, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content- premarket-submissions-software-contained-medical-devices
 What is an SPDF?," encompasses all aspects of a product’s lifecycle, including design, development, release, support, and decommission"
 What is one approach to ensure that the QS regulation is met?, Using an SPDF
 What is the key to assessing device cybersecurity?," Authenticity, which includes integrity"
 What should premarket submissions include information that describes how the above security objectives are addressed by and integrated into the device design?, information
 What is the manufacturer not able to account for?, all potential environments of use
 What is the patient disease state and indications for the radiologic test?, the patient disease state
 What should be addressed in the device design?, these factors
 What is a medical device designed from the outset to be secure throughout the device lifecycle?, its system and/or network of use
 What could fail to convey potential sources of risks?, A failure to disclose all of the communication interfaces or third-party software
 Labeling that does not include sufficient information to explain how to securely configure or update the device may limit the ability of end users to appropriately manage and protect the medical device system?,
 What could lead to compromises in device safety and effectiveness?," Without it, cybersecurity risks could be undisclosed, inappropriately identified, or inappropriately responded to"
 What should Manufacturers take into account when designing a cybersecurity design?, the larger system in which the device may be used
 What is the thermometer used in?, a safety-critical control loop
 What should submitters consider including in premarket submissions to FDA documentation generation from those design controls used during the development of a device with cybersecurity risks?, demonstrate reasonable assurance of safety and effectiveness
" What does the effectiveness of cybersecurity controls degrade as new risks, threats, and attack methods emerge?", the effectiveness of cybersecurity controls
 What is the 21 CFR 807.100(b)(2)(ii)(B))?, 21 CFR 807.100(b)(2)(ii)(B))
 What is the name of the document that collects patient data?, collection sites
 What is the premarket submi?, The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi
 What is the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications?,
 What is the FDA's answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: 510(k)]?,
 What is the importance of addressing cybersecurity risks associated with device connectivity in device design?, The increasingly interconnected nature of medical devices
 What is the primary goal of using an SPDF?, to manufacture and maintain safe and effective devices
 What is the NIST Framework for Improving Critical Infrastructure Cybersecurity commonly referred to as?, NIST Cybersecurity Framework
 What is the JSP 30?, Medical Device and Health IT Joint Security Plan (JSP) 30 and IEC 81001-5-1
 What does FDA believe SPDF processes provide?, important considerations for the development of devices that are safe and effective
 What is the NIST Cybersecurity Framework?, Cybersecurity Framework
 What does FDA not recommend that manufacturers discontinue?," existing, effective processes"
 What is the data poolability of premarket approval applications based on?, foreign clinical data
" What is critical because, given the evolving nature of cybersecurity threats and risks, no device is, or can be, completely secure. security risk management processes?",
 What is the distinction in the performance of these processes?, the scope of possible harm and the risk assessment factors may be different
 What can security risk management result in?, indirect or direct patient harm
 What does AAMI TIR57 detail?, how the security and safety risk management processes should interface to ensure all risks are adequately assessed
" What is the definition of a process that should address the manufacturer’s design, manufacturing, and distribution processes?", QS regulation
 What are the TPLC processes?," design and development, manufacturing, postmarket monitoring, delivering device software and firmware updates, and servicing"
 What describes the security risk management process?, risk management
" What should only occur when all relevant risk information is known, assessed, and appropriately communicated to users?",
" What should only occur when all relevant risk information is known, assessed, and appropriately communicated to users?", Risk transfer
 What is the name of the document that FDA recommends manufacturers generate?, AAMI TIR57
" What should include the documentation elements for the system threat modeling, cybersecurity risk assessment, Software Bill of Materials (SBOM) and component support information?", security risk management report
 What should you justify in accordance with good clinical study design?, why non-U.S. data reflect what is expected for a U.S. population
 What is the purpose of risk transfer?," to include actions taken to manage risk that shifts some or all of the risk to another user, asset, system, network, or geographic"
 Where is the DHS Risk Lexicon available?, https://www.cisa.gov/resources-tools/resources/dhs-risk-lexicon
 What is the foundational for optimizing?, Threat modeling
 What is the purpose of threat modeling?, to inform and support the risk analysis activities
 What should the threat model state about the medical device system?, assumptions
 What is the FDA's recommendation for threat modeling documentation?, demonstrate how the medical device system has been analyzed to identify potential security risks that could impact safety and effectiveness
 What can be performed and/or reviewed during design reviews?, Threat modeling activities
 What does the MDIC/MITRE Playbook for Threat Modeling Medical Devices discuss?, threat modeling process
 What should be assessed for residual risks as part of a cybersecurity risk assessment?, security risks and controls
 What is the fundamental approach performed in safety risk management under ISO 14971?, non-probabilistic approach
 What is a major issue with 510(k) submissions?, foreign data and data poolability
 What is the premarket assessment of exploitability of a cybersecurity risk different from?, exploitability assessment of a vulnerability discovered postmarket
 What could a premarket exploitability assessment assume?, a worst- case assessment and implement appropriate controls
 What should also consider the TPLC of the device?, exploitability of the vulnerability is likely to increase over the device lifecycle
 What is the likelihood of a threat actor to exploit a vulnerability to increase over the device lifecycle?, the ability of a threat actor to exploit that vulnerability is likely to increase
 What should be provided as part of the premarket submission?, The methods used for scoring the risk pre- and post-mitigation and the associated acceptance criteria
" What is the ability of interoperable medical devices to exchange and use information with another medical or nonmedical product, system, or device?", an electronic interface
 What may increase the complexity of interfaces to allow for interoperability?, cybersecurity controls
 What should not be intended to prohibit a user from accessing their device data?, cybersecurity controls
 What should manufacturers document in addition to the recommendations in the Interoperability Guidance?, these considerations
 What does medical devices commonly include?, third-party software components
 What are CADe devices meant to do?," combine values, measurements, or features extracted from the patient radiological data"
 What is the Agency investigating if there is no algorithm training between two tests?, the sponsor is investigating the effect of a new prompt type
 What is the use of component in this guidance consistent with?, the definition in 21 CFR 820.3
 What should device manufacturers document all software components of a device and address or otherwise mitigate risks associated with these software compon?, address or otherwise mitigate risks associated with these software
 What is the Design History File required by?, 21 CFR 820.30(j)
 What is the software supply chain used to demonstrate that manufacturers have adequately ensured cybersecurity risks?, manufacturers have adequately ensured such compliance and documented such history
 What is the name of the method used to establish and maintain custodial control of source code throughout the lifecycle of a device?, source code escrow
 What should users have in the device labeling to allow them to manage risks associated with software components?," known vulnerabilities, configuration specifications, and other relevant security and risk management considerations"
 What does SBOM stand for?, SBOM
 What does source code backup involve?, storing (and updating as needed) a separate copy of the source code
 What does an SBOM help facilitate?, risk management processes
 What should be maintained as part of the device’s configuration management?, SBOM or an equivalent capability
 What should you demonstrate if you are considering data reuse in the evaluation of your CADe device?, that reusing any part of the test data does not introduce unreasonable bias into estimates of CADe performance and that test data integrity is maintained
 What are also referred to as “baseline attributes”?, minimum elements
 What is the acronym for the National Telecommunications and Information Administration (NTIA) Multistakeholder Process on Software Component Transparency document?, “Framing Software Component Transparency: Establishing a Common Software Bill of Materials (SBOM)”
 What is the name of the process that is used to improve software transparency?, Information Administration’s multi-stakeholder process
 What is the software level of support provided through monitoring and maintenance from the software component manufacturer?," software is actively maintained, no longer maintained, abandoned"
 What should a manufacturer provide a justification for if the information cannot be included in the premarket submission?, why the information cannot be included in the premarket submission
 What should device manufacturers provide in premarket submissions for components with known vulnerabilities?, • A safety and security risk assessment of each known vulnerability (including device and system impacts); and • Details of applicable safety and security risk controls to address the vulnerability.
 What may have security implications and may also be considered vulnerabilities?, Some anomalies discovered during development or testing
 What is the CWE?, Common Weakness Enumeration
 What might the impact of the anomaly occur sporadically and be assessed to be acceptable from a software risk perspective?, the impact of the anomaly
 What may continue to be identified throughout the device’s TPLC?, Cybersecurity risks
 What is a “firewall”?," to ensure those outside of the regulatory assessment team (e.g., algorithm developers) are completely insulated from knowledge of the radiology images and radiological data"
 What can be used to quickly identify vulnerability impacts once a device is released?, threat modeling
 What is the most common type of device that is not marketed but still in use?, marketed devices
 What is needed based on postmarket vulnerabilities and general postmarket cybersecurity risk management?, a new premarket submission
 What is important to ensure that device design appropriately addresses cybersecurity in compliance with the QS regulation?, device design
 What is the length from vulne?, Duration
 What should be provided over multiple time frames based on volume or in response to process or procedure changes to increase efficiencies of these measures over time?, Averages
" What are risks introduced by device reliance on hospital networks, cloud infrastructure, or “other functions” defined in?"," those introduced by device reliance on hospital networks, cloud infrastructure, or “other functions”"
 What does A security architecture definition process55 demonstrate?, that the risks considered during the risk management process are adequately controlled
 What must a manufacturer establish and maintain under 21 CFR 820.30(c)?, procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device
 What does 21 CFR 820.30(d) state?, design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.
" What is the purpose of a ""firewall""?", to insulate personnel responsible for proposing interim protocol changes from knowledge of interim comparative results
 What does NIST 800-160 vol. 1 rev. 1 state?, Engineering Trustworthy Secure Systems
 What does the process also ascertain?," vulnerability and susceptibility to disruptions, hazards, and threats"
 What does the details of the security context and trust-boundaries enable?, the identification of the parts of the medical device system in or through which incidents might occur
 What should manufacturers analyze to understand the full environment and context in which the device is expected to operate?, the entire system
 What do FDA recommend that architecture information take?," the form of “views,” and that these views be provided during premarket submissions to demonstrate safety and effectiveness"
 What is FDA's recommendation for security controls?, ways to document the resultant security architecture
 What must a manufacturer establish and maintain under 21 CFR 820.30(c)?, procedures
 What is the acronym for the Building Code for Medical Device Software Security?, IEC 81001-5-1
 What allows manufacturers to achieve the security objectives outlined in Section IV?, Security controls
 What is the name of the category where security controls should be applied across the system architecture?, Appendix 1
 What do you do when you contemplate the reuse of any test data?, randomly select the data from a larger database that grows over time
" What should manufacturers submit in their premarket submissions to demonstrate that the security controls for the categories above, and further detailed in the recommendations in Appendix 1 have (1) been implemented, and (2) been tested in order to validate that they were effectively implemented.?",
 What is the FDA's nonbinding recommendation for cybersecurity risk management throughout the device lifecycle?, 22 Contains Nonbinding Recommendations
 What can these views be used to help identify?, impacted fun
 What can architecture views contribute to the demonstration of safety and effectiveness in premarket submissions?, demonstration of safety and effectiveness
 What is the most effective way to provide threat modeling information to FDA?, These views can therefore be effective way to provide threat modeling information to FDA and will naturally scale the documentation provided with the cybersecurity risk of the device.
" What should security context, domains, boundaries, critical user roles, and external interfaces of the medical device system define?", security context
 What should exist throughout the cybersecurity risk management documentation?, traceability
 What should manufacturers provide if one of the views listed above is not appropriate?, an explanation for why the view is not included in the premarket submission
 What should a global system view describe?, the overall medical device system
 What do you maintain to track each time the data is accessed?, a data access log
 What is the possibility of a multi-patient Harm view?," When devices are capable of connecting (wired or wirelessly) to another medical or non-medical product, to a network, or to the Internet"
 What can be hacked to perform a device function?, a non-device function
 What can a multiple-device compromise have severe impacts for multiple patients?, impact to the device itself and/or to healthcare facility operations
 What is the view that should include the information recommended in Appendix 2?, multi-patient harm view
" What should describe the end-to-end process that permits software updates and patches to be provided (i.e., deployed) to the device?", updateability and patchability view
 What should the device design provide for?, the protection of the end-to-end path and take into account any additional cybersecurity risk created or posed by those non-manufacturer-controlled technologies
 What should security use cases cover?," various operational states of elements in the medical device system (e.g., power on, standby, transition states) and assess clinical functionality states of the medical device system"
 What should each view include?, detailed information as recommended in Appendix 2
 What are closely related disciplines?, software development and cybersecurity
 What must a manufacturer establish and maintain procedures for verifying?, device design
 What did you do to ensure that the new CADe algorithm was fixed in advance?," ensuring that you fixed the new CADe algorithm in advance (i.e., before application to the test set); and (3) providing information concerning the extent to which you used the same test set or a subset thereof for testing other CADe algorithms or designs, including results reported to the Agency as well as non-reported results"
 What type of testing should be submitted in the premarket submission?, Security testing
 What should Manufacturers provide evidence of in their submission?, their boundary analysis and rationale for their boundary assumptions
 What should manufacturers ensure the adequacy of?, cybersecurity risk control
 What is the name of the tool used for?, Vulnerability chaining
 What may be necessary to use third parties to ensure an appropriate level of independence between the two groups?, vulnerabilities or other issues revealed during testing are ap
 What should manufacturers provide for all testing?, their assessment of any findings including rationales for not implementing or deferring any findings to future releases
 What may be small or unlikely in relation to a medical device system?, impact on medical device system functionality
 What should the plans include the vulnerabilities that future software releases will address?, anticipated timelines for release
 What can ensure that security issues are addressed prior to impacting release timelines?, Security testing early in development
 What is the key to ensuring safe and effective use and integration of devices and systems?, Cybersecurity Transparency
 What is the chance that you evaluate a new CADe algorithm in a subsequent study using the same test data set that you used for a prior CADe algorithm?, substantially reduce the chance
 What is a medical device deemed misbranded if its labeling is false or misleading in any particular?, section 502(a)(1)
 What does FDA believe informing users of security information through labeling may be an important part of?, design and development activities
 What should be detailed and considered for inclusion as tasks during usability testing?, Any risks transferred to the user
 What is the name of the part of the Guidance that FDA issued on applying Human Factors and Usability Engineering to Medical Devices?, Part 4-1: Product security development life-cycle requirements
 What is the exact location in the labeling for specific types of information?," operator’s manual, security implementation guide"
 What should be understandable to the intended audience?, Instructions to manage cybersecurity risks
 What is the name of the product specifications that are related to recommended cybersecurity controls?, device instructions and product specifications
 What should users be able to do with ports in their device?," indicate whether the ports are incoming, outgoing, or both, along with approved destination end-points"
 What should users do upon detection of a cybersecurity vulnerability or incident?, respond
 What should the SBOM be in?, machine-readable format
 What are the subsets of test sets that you have never been used before?, the portion of the test set that you have never been used before
 What could be security event types?, configuration changes
 What is the name of the feature that disabling ports/communications?, backup mode
 What is the name of the end point protections that Secure configurations may include?," allow lists, deny lists"
 What is the name of the security event management software?, Security Information and Event Management
 What is the manufacturer unable to provide at the end of support?, security patches or software updates
 What is the Manufacturer Disclosure Statement for Medical Device Security outlined in?, MDS266
 What is the 21 CFR 820.100?, vulnerabilities that are identified after releasing the device
 What is available at https://www.nema.org/standards/view/manufacturer-disclosure-statement-for-medical-device-security 67 Available at https://healthsectorcouncil.org/thejoint-security-plan/ 30 Contains Nonbinding Recommendations addressed how to maintain the safety and effectiveness of the device after marketing authorization is achieved.?,
 What is Patching capability?, rate at which update can be delivered to devices
 What is the name of the nonbinding recommendation appendix?, Security Control Categories and Associated Recommendations
 What does the reference standard indicate for patient data?, whether the disease/condition/abnormality is present
 What is Authentication of information69?," where the device and the system in which it operates are able to prove that information originated at a known and trusted source, and that the information has not been altered in transit between the original source and the point at which authenticity is verified"
 What is the purpose of authentication?," to prove the identity of an endpoint (whether hardware and/or software) from which it is sending and/or receiving information, or authorized user/operator at that endpoint"
 What should devices prove to prove the authenticity of information that they generate?, the authenticity of information that they generate
 What is the state of currently running software?, state
 What is the definition of information?," software/firmware itself, as well as input and output data"
 What is the main reason for weak schemes?, an unauthorized user can easily emulate the correct behavior and appear to be authorized
 What is the purpose of cryptographic keys?, the integrity of the devices that hold or otherwise leverage those keys
 What should be considered when possible?, Hardware-based security solutions
 What should the device and the server mutually authenticate and limit?, the connection is initiated over one or more existing trusted channels
 What can be done with the use o Answer: Strengthen password protections?,
 What is the use of the acronym CADe for computer-assisted detection known as?, CADe
 What is the name of the clinician who makes the reference standard determination?, clinical truther(s)
 What is the definition of security strength in Appendix 5?, Terminology
 What do cyclic redundancy checks do not provide?, integrity or authentication protections
 What is an authorization scheme used for?, as a defensive measure
" What should be applied to users, system functions, and others?", the principle of least privileges71
 What is the preferred authentication scheme?, cryptographically proven designs
 What is a medical device programmer capable of?, Near-Field Communications (NFC)
" What is the principle that a security architecture should be designed so that each entity (e.g., user, asset) is granted the minimum system resources and authorizations that the entity needs to perform its function?", least privilege
 What is the name of the device that is not expres?, devices to “deny by default”
 What is one form of denying authorization?, Ignoring requests
 What are the recommendations specifically related to?, selection and implementation of the underlying cryptographic scheme used by a device and the larger system in which it operates
 What do you provide for truthing that relies on the interpretation by a reviewing clinician?, the instructions conveyed to them prior to participating in the truthing process
 What is the expected to be considered cryptographically strong throughout the service life of the device?, cryptographically strong
 What should design a system architecture and implement security controls to prevent?, a situation where the full compromise of any single device can result in the ability to reveal keys for other devices
 What is the NIST FIPS 140-2 Suite B available at?, https://csrc.nist.gov/CSRC/media/projects/cryptographic-module- validation-program/documents/security-policies/140sp2851.pdf
 What can be employed to help meet this objective?, public- key cryptography
" What are many cybersecurity incidents caused, at their root, by the violation of some form of device integrity?"," the violation of stored code, stored and operational data, or execution state"
 What should be used to Authenticate firmware and software?," signatures, message authentication codes (MACs)"
 What is the name of the authentication that is absent or fails in d software updates?, cryptographic authentication
 What is the name of the FDA webpage that provides information regarding UDI?, FDA’s webpage
 What is the definition of “whitelist” in NIST SP 800-128?, NIST SP 800-128
 What should be verified to ensure that data is not modified in transit or at rest?, integrity of all incoming data
 What is any specific criteria used as part of the truthing process?, any specific criteria
 What is HIDS/HIPS?, Host-based Intrusion Detection/Prevention Systems
 What could lead to patient harm?, disclosure
 What could lead to unauthorized use/abuse of device functionality?, disclosure
 What are these critical capabilities?, Event detection and logging
 What should logs include if possible?, storage capabilities
 What is an example of a security event?, sending requests to unknown entities
 What may secure configurations include?, endpoint protections
 What is recommended to qualify multiple options to support user preferences for different options?, Manufacturers
 What is the NIST SP 800-86 available at?, https:
 What should not be the same as those who participate in the core clinical performance assessment of the CADe device?, ians participating in the truthing process
 What does digital forensics mean?," The application of science to the identification, collection, examination, and analysis, of data while preserving the integrity of the information and maintaining a strict chain of custody for the data"
 What should be designed to facilitate the performance of variant analyses such that the same vulnerabilities can be identified across device models and product lines?," Design devices to notify users when malfunctions or anomalous device behavior, including those potentially related to a cybersecurity breach, are detected"
 What are cyber-resiliency capabilities important for?, medical devices
 What is the name of the dware-backed trusted execution environments?, dware-backed
 What should be resilient to possible cyber incident scenarios?," network outages, Denial of Service,80 excessive bandwidth usage by other products, disrupted quality of service (QoS),81 and/or excessive jitter82"
 What is the HCIC TF?,
 What is the HCIC TF Report on Improving Cybersecurity in the Health Care Industry?, Improving Cybersecurity in the Health Care Industry
 What does CNSSI stand for?, Committee on National Security Systems
 What can design devices to anticipate the need for?, software and firmware patches and updates to address future cybersecurity vulnerabilities
 What should consider cybersecurity patches and updates that are independent of regular feature update cycles?, cybersecurity patches and updates
 What should be considered such that third-party company goes out of business or stops supporting a licensed product?, contingency plans
 What is an example of a potential source of Bias in a Ret Submission?, scanned films
 What is the FDA's recommendation for manufacturers to provide detailed information for in Section V.B.2?, views identified in Section V.B.2
 What is another method used to describe the architecture of a medical device?, call-flow views
 What should architecture views provide specific protocol details of?, communication pathways between parts of the medical device system
 What is the most important asset that gineers and reviewers should be able to cross?, intermediate assets
 What is a security-relevant analysis?, the ability to construct and follow a detailed trace for important communication paths
 What should be included in Detailed diagrams and supporting explanatory text that identify all medical device system assets?, Device hardware
 What are some nonbinding recommendations for nonbinding recommendations?," Applications, hardware, and/or other supporting assets that directly interact with the targeted device"
 What is an example of a communication path when there is at least one intermediate asset?, an app
 What is the name of the access control model for every asset?, privileges
 What is the purpose of an “handoff” sequence?, how is their integrity/authenticity assured
 What can often be minimized or at least mitigated through good study design?, sources of statistical bias
 What is the name of the strength indicators in a cryptographic method?, key bit length
 What are some examples of verification credentials?," certificates, asymmetric keys, or shared keys"
" What is generated, stored, configured, transferred, and maintained?"," password, key"
 What is another assurance of security properties?, verification of session identifiers
 What is the need to balance innovation and security in designs especially during clinical trials?, FDA
 What does 21 CFR 812.25 require manufacturers to provide as a part of their IDE application?, an investigational plan
" What is included in the 21 CFR 812.25(c), (d)?", updateability/patchability views
 What does not preclude the possibility of future cybersecurity questions or concerns being raised during review of a subsequent marketing application?, approval of an IDE based on the documentation recommended above
 What is the term for the time when a device is submitted for marketing authorization?, Cybersecurity improvements will likely be needed between the time of clinical trials and when the device is submitted for marketing authorization
 What is recommended for all premarket submissions for devices with potential cybersecurity risks?, each type of documentation identified throughout the guidance
 What is Statistical analysis of diagnostic performance based on?, subjects verified for presence or absence of the condition of interest by the reference standard
 What is the purpose of the table?, to summarize the specific documentation elements identified throughout the guidance for premarket submissions
 What is the table in the table that represents one possible way to organize the recommended information?, This table
 What is the only view that a SaMD product will likely need to have for each of the global system?, multi-patient harm
 What is the most common use of a premarket document?, clinical use cases
 What is the type of Premarket Guidance Section(s) IDE Submission* Submission Documentation?,
 What is not specifically recommended Assessment?, Unresolved Section V.A.5
 What is the name of the section that could be helpful to submit?, Architecture Views Section V.B.
 What is the name of the section that is not specifically recommended Labeling Section VI.A.?, Section V.C.
 What does “recommended” refer to?, the elements of an IDE submission FDA discusses in Appendix 3 of this document
 What process should a manufacturer use to make a recommendation?, FDA Q-submission process
 What is introduced when subjects selected for study are not representative of the intended use population?, Selection bias
 What is anything that has value to an individual or an organization?, Asset
 What is the right or a permission that is granted to a system entity to access a system resource?, Authorization
 What defines the security boundary for an information system?, Boundary Analysis
 What is the 89 definition adapted from?, CNSSI 4009-2015 Committee on National Security Systems (CNSS) Glossary
" What is a safeguard or countermeasure deployed, in lieu of, or in the absence of controls designed in by a device manufacturer?", Nonbinding Recommendations Compensating Controls
 What is Configuration?," the possible conditions, parameters, and specifications with which a device or system component can be described or arranged"
" What is the process of preventing unauthorized access, modification, misuse or denial of use?", Cybersecurity
" What is the process that includes proper identification, authorization for disposition, and sanitization of the equipment, as well as removal of Patient Health Information (PHI) or software, or both?",
 What is the purpose of a system asset?, a specified intended use
 What is the NIST guide for Security-Focused Configuration Management of Information Systems called?, NIST SP 800-128 Rev. 4
 What may eliminate or mitigate selection bias?, Random or consecutive sampling of subjects
 What is the form called that conceals the data’s original meaning?,ciphertext
 What is the software program or set of instructions programmed on the flash read-only memory of a hardware device?, Firmware
 What is the practice of reducing a system's vulnerability by reducing its attack surface?, Hardening
 What is the lifecycle of a medical device?, all phases in the life of a medical device
 What is a “repair job” for a piece of programming also known as?, a “fix”
 What is provided to manage and track the installation of patches?, a special program
" What is the term for use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior?", Reasonably foreseeable misuse
 What is the Security Architecture?," a set of physical and logical security-relevant representations (i.e., views) of system architecture"
 What is the purpose of security architecture?, the placement of security-relevant elements within the security domains
 What is the definition of Information System Resilience cited from?, NISTSP 800-53 Rev. 4
 What can bias the CADe effect?, Enriching a CADe study with subjects that are difficult to diagnose
 What is the term that describes secure product development and risk management?, SPDF
 What is a process that evaluates and controls threat-based risks?, Security Risk Management
 What are the software components in an SBOM?," commercial, open source, off- the-shelf, and custom software components"
 What is a threat?," any circumstance or event with the potential to adversely impact the device, organizational operations (including mission, functions, image, or reputation), organizational assets, individuals, or other organizations through an information system via unauthorized access, destruction, disclosure, modification of information, and/or denial of service.119"
" What is a methodology for optimizing system, product, network, application, and connection security?", Threat modeling
 What is the definition of Framing Software Component Transparency: Establishing a Common Software Bill of Materials?, SBOM
 What is the definition adapted from?, NIST SP 800-53
 What is the term for the ease and timeliness with which a device and related assets can be changed for any reason?, Updatability and Patchability
 What does the sequential exploit of multiple vulnerabilities require in order to be exploited?, successful completion of prior exploits in order to be exploited
 When was the 21st Century Cures Act enacted?," December 13, 2016"