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updated RST with the reference and new disclaimer information

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  1. color2_module/static/RST.html +36 -0
  2. color2_module/templates/color2_index.html +3 -1
  3. efficiency_module/static/RST.html +36 -0
  4. efficiency_module/templates/efficiency_index.html +2 -2
  5. exposure2_module/static/RST.html +36 -0
  6. exposure2_module/templates/exposure2_index.html +2 -1
color2_module/static/RST.html ADDED
@@ -0,0 +1,36 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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+ <!DOCTYPE html>
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+ <html lang="en">
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+ <head>
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+ <title>CHRIS-RST</title>
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+ <link rel="stylesheet" href="styles.css">
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+ <meta charset="UTF-8">
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+
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+ </head>
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+
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+ <header>
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+ <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators (CHRIS) - Color additives</h1>
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+ </header>
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+ <h2>Regulatory Science Tool (RST) Reference</h2>
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+ <ul>
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+ <li>RST Reference Number: RST24BT02.01</li>
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+ <li>Date of Publication: 09/24/2023</li>
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+ <li>Recommended Citation: U.S. Food and Drug Administration. (2023). CHemical RISk calculators (CHRIS) – Color Additives (v2) (RST24BT02.01).
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+ <a href="https://cdrh-rst.fda.gov/chemical-risk-calculators-chris-color-additives-v2">https://cdrh-rst.fda.gov/chemical-risk-calculators-chris-color-additives-v2</a>
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+ </li>
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+ </ul>
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+ <h2>Disclaimer</h2>
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+ <p>
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+ About the Catalog of Regulatory Science Tools
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+
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+ The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer- reviewed resource for
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+ stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These
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+ tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools
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+ that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL)
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+ developed. These tools use the most innovative science to support medical device development and patient access to
30
+ safe and effective medical devices. If you are considering using a tool from this catalog in your marketing
31
+ submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has
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+ not evaluated the suitability of these tools within any specific context of use. You may request feedback or
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+ meetings for medical device submissions as part of the Q-Submission Program.
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+
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+ For more information about the Catalog of Regulatory Science Tools, email <a href="mailto:OSEL_CDRH@fda.hhs.gov">OSEL_CDRH@fda.hhs.gov</a>.
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+ </p>
color2_module/templates/color2_index.html CHANGED
@@ -20,7 +20,9 @@
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  <p> For details on how to use the CHRIS color additive module, please click the information icons next to each section header and read the
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  <a href="{{url_for('.static', filename='COU.html')}}"> Context of Use (CoU)</a>, which includes limitations of use. Answers to frequently asked questions can be
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- found <a href="{{url_for('.static', filename='FAQ.html')}}"> here</a>. For a history of updates, please see the <a href="{{url_for('.static', filename='Changelog.html')}}"> changelog</a>. </p>
 
 
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  <body>
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  <p> For details on how to use the CHRIS color additive module, please click the information icons next to each section header and read the
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  <a href="{{url_for('.static', filename='COU.html')}}"> Context of Use (CoU)</a>, which includes limitations of use. Answers to frequently asked questions can be
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+ found <a href="{{url_for('.static', filename='FAQ.html')}}"> here</a>. For reference and disclaimer information,
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+ please see the <a href="{{url_for('.static', filename='RST.html')}}"> RST information</a> page.
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+ </p>
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  <body>
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efficiency_module/static/RST.html ADDED
@@ -0,0 +1,36 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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+ <!DOCTYPE html>
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+ <html lang="en">
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+ <head>
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+ <title>CHRIS-RST</title>
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+ <link rel="stylesheet" href="styles.css">
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+ <meta charset="UTF-8">
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+
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+ </head>
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+
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+ <header>
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+ <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators (CHRIS) - Extraction efficiency</h1>
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+ </header>
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+ <h2>Regulatory Science Tool (RST) Reference</h2>
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+ <ul>
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+ <li>RST Reference Number: RST24BT03.01</li>
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+ <li>Date of Publication: 09/24/2023</li>
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+ <li>Recommended Citation: U.S. Food and Drug Administration. (2023). CHemical RISk calculators (CHRIS) – Extraction
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+ Efficiency (RST24BT03.01). <a href="https://cdrh-rst.fda.gov/chemical-risk-calculators-chris-extraction-efficiency">https://cdrh-rst.fda.gov/chemical-risk-calculators-chris-extraction-efficiency</a>
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+ </li>
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+ </ul>
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+ <h2>Disclaimer</h2>
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+ <p>
23
+ About the Catalog of Regulatory Science Tools
24
+
25
+ The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer- reviewed resource for
26
+ stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These
27
+ tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools
28
+ that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL)
29
+ developed. These tools use the most innovative science to support medical device development and patient access to
30
+ safe and effective medical devices. If you are considering using a tool from this catalog in your marketing
31
+ submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has
32
+ not evaluated the suitability of these tools within any specific context of use. You may request feedback or
33
+ meetings for medical device submissions as part of the Q-Submission Program.
34
+
35
+ For more information about the Catalog of Regulatory Science Tools, email <a href="mailto:OSEL_CDRH@fda.hhs.gov">OSEL_CDRH@fda.hhs.gov</a>.
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+ </p>
efficiency_module/templates/efficiency_index.html CHANGED
@@ -30,8 +30,8 @@ table, th, td {
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  <p>
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  For details on how to use the CHRIS extraction efficiency module, please click the information icons next to each field and read the
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  <a href="{{url_for('.static', filename='efficiency_COU.html')}}"> context of use (COU)</a>, which includes limitations of use.
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- You are accessing v.1.0 on <script> document.write(new Date().toLocaleDateString()); </script>. For a history of updates,
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- please see the <a href="{{url_for('.static', filename='Changelog.html')}}"> changelog</a>.
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  </p>
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  </header>
 
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  <p>
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  For details on how to use the CHRIS extraction efficiency module, please click the information icons next to each field and read the
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  <a href="{{url_for('.static', filename='efficiency_COU.html')}}"> context of use (COU)</a>, which includes limitations of use.
33
+ You are accessing v.1.0 on <script> document.write(new Date().toLocaleDateString()); </script>. For reference and disclaimer information,
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+ please see the <a href="{{url_for('.static', filename='RST.html')}}"> RST information</a> page.
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  </p>
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  </header>
exposure2_module/static/RST.html ADDED
@@ -0,0 +1,36 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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+ <!DOCTYPE html>
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+ <html lang="en">
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+ <head>
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+ <title>CHRIS-RST</title>
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+ <link rel="stylesheet" href="styles.css">
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+ <meta charset="UTF-8">
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+
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+ </head>
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+
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+ <header>
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+ <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators (CHRIS) - Bulk chemicals (v2)</h1>
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+ </header>
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+ <h2>Regulatory Science Tool (RST) Reference</h2>
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+ <ul>
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+ <li>RST Reference Number: RST24BT01.01</li>
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+ <li>Date of Publication: 09/24/2023</li>
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+ <li>Recommended Citation: U.S. Food and Drug Administration. (2023). CHemical RISk calculators (CHRIS) – Bulk chemicals (v2) (RST24BT01.01).
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+ <a href="https://cdrh-rst.fda.gov/chemical-risk-calculators-chris-bulk-chemicals-v2">https://cdrh-rst.fda.gov/chemical-risk-calculators-chris-bulk-chemicals-v2</a>
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+ </li>
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+ </ul>
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+ <h2>Disclaimer</h2>
22
+ <p>
23
+ About the Catalog of Regulatory Science Tools
24
+
25
+ The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer- reviewed resource for
26
+ stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These
27
+ tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools
28
+ that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL)
29
+ developed. These tools use the most innovative science to support medical device development and patient access to
30
+ safe and effective medical devices. If you are considering using a tool from this catalog in your marketing
31
+ submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has
32
+ not evaluated the suitability of these tools within any specific context of use. You may request feedback or
33
+ meetings for medical device submissions as part of the Q-Submission Program.
34
+
35
+ For more information about the Catalog of Regulatory Science Tools, email <a href="mailto:OSEL_CDRH@fda.hhs.gov">OSEL_CDRH@fda.hhs.gov</a>.
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+ </p>
exposure2_module/templates/exposure2_index.html CHANGED
@@ -26,7 +26,8 @@
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  <p> For details on how to use the CHRIS bulk chemical module, please click the information icons next to each section header and read the
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  <a href="{{url_for('.static', filename='exposure_COU.html')}}"> context of use (COU)</a>, which includes limitations of use.
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- For a history of updates, please see the <a href="{{url_for('.static', filename='Changelog.html')}}"> changelog</a>. </p>
 
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  <body>
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  <p> For details on how to use the CHRIS bulk chemical module, please click the information icons next to each section header and read the
28
  <a href="{{url_for('.static', filename='exposure_COU.html')}}"> context of use (COU)</a>, which includes limitations of use.
29
+ For reference and disclaimer information,
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+ please see the <a href="{{url_for('.static', filename='RST.html')}}"> RST information</a> page.</p>
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  <body>
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