initial changes based on qual feedback

static/COU.html

@@ -1,6 +1,6 @@
 <h1 id="context-of-use-cou">Context of Use (COU)</h1>
 <p>The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or testing to demonstrate acceptable biological risk. The output of CHRIS is a conservative margin of safety (MOS = toxicological safety limit ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric medical device component. Based on the MOS value, the calculator determines if further assessment of one or more biocompatibility endpoints is necessary for the CA and/or associated impurities.</p>
-<p>Because CHRIS only addresses CAs, a favorable outcome by CHRIS does not imply acceptable biological risk for a finished, sterilized device. However, in addition to providing guidance to device manufacturers on acceptable levels of CA in a particular device, CHRIS can potentially be used to:</p>
+<p>Because CHRIS only addresses CAs, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device. CHRIS is also not intended to establish device classification or identify biocompatibility requirements. However, in addition to providing guidance to device manufacturers on acceptable levels of CA in a particular device, CHRIS can potentially be used to:</p>
 <ul>
 <li>reduce the amount of biocompatibility testing needed following a supplier or manufacturing changes related to only the presence of the CA in the device;</li>
 <li>obviate the need for additional biocompatibility testing when existing biocompatibility testing is inconclusive with respect to a CA. For example, the when biocompatibility extracts are colored, yet pass the testing (note that the presence of colored extracts may give rise to additional concerns unrelated to the color additive);</li>

static/COU.md

@@ -3,7 +3,7 @@
 
 The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs).  These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or testing to demonstrate acceptable biological risk.  The output of CHRIS is a conservative margin of safety (MOS = toxicological safety limit ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric medical device component.  Based on the MOS value, the calculator determines if further assessment of one or more biocompatibility endpoints is necessary for the CA and/or associated impurities.
 
-Because CHRIS only addresses CAs, a favorable outcome by CHRIS does not imply acceptable biological risk for a finished, sterilized device.  However, in addition to providing guidance to device manufacturers on acceptable levels of CA in a particular device, CHRIS can potentially be used to:
+Because CHRIS only addresses CAs, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device.  CHRIS is also not intended to establish device classification or identify biocompatibility requirements.  However, in addition to providing guidance to device manufacturers on acceptable levels of CA in a particular device, CHRIS can potentially be used to:
 
 * reduce the amount of biocompatibility testing needed following a supplier or manufacturing changes related to only the presence of the CA in the device;
 * obviate the need for additional biocompatibility testing when existing biocompatibility testing is inconclusive with respect to a CA. For example, the when biocompatibility extracts are colored, yet pass the testing (note that the presence of colored extracts may give rise to additional concerns unrelated to the color additive);

static/README.html

@@ -1,7 +1,7 @@
 <h1 id="color-hazard-and-risk-calculator-chris">Color Hazard and RISk calculator (CHRIS)</h1>
 <h2 id="overview">Overview</h2>
-<p>The CHemical RISk calculator (CHRIS) is a tool under development within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). The tool enables the user to perform rapid, screening level toxicological risk assessments of color additives and additives and impurities associated with the color additive that might be released from a polymer medical device component. CHRIS applies a model that computes an exposure estimate and compares the result to a tolerable exposure (TE) or threshold of toxicological concern (TTC) value. The tool assists the user in determining (a) whether the toxicological risk of a color additive associated substance should be further assessed and/or (b) the potential impact of the substance on device biocompatibility.</p>
-<p><strong>Disclaimer: CHRIS only addresses risk associated with the presence of color additives and additives and impurities associated with the color additive. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for a finished, sterilized device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS.</strong></p>
+<p>The Color Hazard and RISk calculator (CHRIS) is a tool under development within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). The tool enables the user to perform rapid, screening level toxicological risk assessments of color additives and additives and impurities associated with the color additive that might be released from a polymer medical device component. CHRIS applies a model that computes an exposure estimate and compares the result to a tolerable exposure (TE) or threshold of toxicological concern (TTC) value. The tool assists the user in determining (a) whether the toxicological risk of a color additive associated substance should be further assessed and/or (b) the potential impact of the substance on device biocompatibility.</p>
+<p><strong>Disclaimer: CHRIS only addresses risk associated with the presence of color additives and additives and impurities associated with the color additive. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS. Because there may be addition restrictions based on specific device guidance and code of federal regulation (CFR) listings, users should also review the relevant documents for their device type and color additive.</strong></p>
 <h2 id="important-considerations">Important considerations</h2>
 <ol type="1">
 <li><p>CHRIS assists in screening the potential risk of a color additive associated substance in a polymer medical device component. Because color additives and concentrates may contain multiple distinct substances, e.g. impurities and carrier resins, CHRIS can be used to evaluate each substance present in the component individually.</p></li>

static/README.md

@@ -2,9 +2,9 @@
 
 ## Overview
 
-The CHemical RISk calculator (CHRIS) is a tool under development within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). The tool enables the user to perform rapid, screening level toxicological risk assessments of color additives and additives and impurities associated with the color additive that might be released from a polymer medical device component. CHRIS applies a model that computes an exposure estimate and compares the result to a tolerable exposure (TE) or threshold of toxicological concern (TTC) value. The tool assists the user in determining (a) whether the toxicological risk of a color additive associated substance should be further assessed and/or (b) the potential impact of the substance on device biocompatibility.
+The Color Hazard and RISk calculator (CHRIS) is a tool under development within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). The tool enables the user to perform rapid, screening level toxicological risk assessments of color additives and additives and impurities associated with the color additive that might be released from a polymer medical device component. CHRIS applies a model that computes an exposure estimate and compares the result to a tolerable exposure (TE) or threshold of toxicological concern (TTC) value. The tool assists the user in determining (a) whether the toxicological risk of a color additive associated substance should be further assessed and/or (b) the potential impact of the substance on device biocompatibility.
 
-**Disclaimer: CHRIS only addresses risk associated with the presence of color additives and additives and impurities associated with the color additive. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for a finished, sterilized device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS.**
+**Disclaimer: CHRIS only addresses risk associated with the presence of color additives and additives and impurities associated with the color additive. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS.  Because there may be addition restrictions based on specific device guidance and code of federal regulation (CFR) listings, users should also review the relevant documents for their device type and color additive.**
 
 ## Important considerations
 

templates/index.html

@@ -56,7 +56,7 @@ body {font-family: Arial, Helvetica, sans-serif;}
    <h2>Color Hazard and RISk calculator (CHRIS)</h2>
 </header>
 
-<p><strong>Disclaimer: CHRIS only addresses risk associated with the presence of color additives and additives and impurities associated with the color additive. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for a finished, sterilized device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS.</strong></p>
+<p><strong>Disclaimer: CHRIS only addresses risk associated with the presence of color additives and additives and impurities associated with the color additive. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS.  Because there may be addition restrictions based on specific device guidance and code of federal regulation (CFR) listings, users should also review the relevant documents for their device type and color additive.  </strong></p>
 
 
 <p> For details on how to use CHRIS, please read the <a href="{{url_for('static', filename='README.html')}}"> instructions.</a> and <a href="{{url_for('static', filename='COU.html')}}"> context of use (COU)</a>. Answers to frequently asked questions can be found <a href="{{url_for('static', filename='FAQ.html')}}"> here</a>.</p>
@@ -88,7 +88,7 @@ Amount (mg): <input name="amount" id="amount" value="1.0" step="any" min="0.0000
 <script type="text/javascript">
 
 function caCheck() {
-    var caMW = ['{{caMW[0]}}','{{caMW[1]}}','{{caMW[2]}}','{{caMW[3]}}','{{caMW[4]}}','{{caMW[5]}}','{{caMW[6]}}','{{caMW[7]}}','{{caMW[8]}}','{{caMW[9]}}','{{caMW[10]}}','{{caMW[11]}}','{{caMW[12]}}','{{caMW[13]}}']
+    var caMW = ['{{caMW[0]}}','{{caMW[1]}}','{{caMW[2]}}','{{caMW[3]}}','{{caMW[4]}}','{{caMW[5]}}','{{caMW[6]}}','{{caMW[7]}}','{{caMW[8]}}','{{caMW[9]}}','{{caMW[10]}}','{{caMW[11]}}','{{caMW[12]}}','{{caMW[13]}}'];
     var iCA = parseInt(document.getElementById("CA").selectedIndex);
 
     document.getElementById("MW").value = parseFloat(caMW[iCA]);
@@ -99,7 +99,7 @@ function caCheck() {
     } 
     if (iCA >= 11) {
       document.getElementById('otherID').style.visibility = 'visible';
-      document.getElementById('chemName').value = "ENTER CHEMICAL NAME"
+      document.getElementById('chemName').value = "ENTER CHEMICAL NAME";
     } else {
       document.getElementById('otherID').style.visibility = 'hidden';
     }