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  1. static/README.html +1 -1
  2. static/README.md +1 -1
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  <h1 id="color-hazard-and-risk-calculator-chris">Color Hazard and RISk calculator (CHRIS)</h1>
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  <h2 id="overview">Overview</h2>
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  <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>
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- <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>
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  <h2 id="important-considerations">Important considerations</h2>
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  <ol type="1">
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  <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>
 
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  <h1 id="color-hazard-and-risk-calculator-chris">Color Hazard and RISk calculator (CHRIS)</h1>
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  <h2 id="overview">Overview</h2>
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  <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>
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+ <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 additional 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>
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  <h2 id="important-considerations">Important considerations</h2>
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  <ol type="1">
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  <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>
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  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.
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- **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.**
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  ## Important considerations
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  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.
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+ **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 additional 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.**
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  ## Important considerations
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  <h2>Color Hazard and RISk calculator (CHRIS)</h2>
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  </header>
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- <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>
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  <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>
 
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  <h2>Color Hazard and RISk calculator (CHRIS)</h2>
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  </header>
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+ <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 additional 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>
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  <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>