dmsaylor's picture
updated RST with the reference and new disclaimer information
76da1b2
<!DOCTYPE html>
<html lang="en">
<head>
<title>CHRIS-RST</title>
<link rel="stylesheet" href="styles.css">
<meta charset="UTF-8">
</head>
<header>
<h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators (CHRIS) - Bulk chemicals (v2)</h1>
</header>
<h2>Regulatory Science Tool (RST) Reference</h2>
<ul>
<li>RST Reference Number: RST24BT01.01</li>
<li>Date of Publication: 09/24/2023</li>
<li>Recommended Citation: U.S. Food and Drug Administration. (2023). CHemical RISk calculators (CHRIS) – Bulk chemicals (v2) (RST24BT01.01).
<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>
</li>
</ul>
<h2>Disclaimer</h2>
<p>
About the Catalog of Regulatory Science Tools
The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer- reviewed resource for
stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These
tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools
that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL)
developed. These tools use the most innovative science to support medical device development and patient access to
safe and effective medical devices. If you are considering using a tool from this catalog in your marketing
submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has
not evaluated the suitability of these tools within any specific context of use. You may request feedback or
meetings for medical device submissions as part of the Q-Submission Program.
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>.
</p>