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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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| <h2>Regulatory Science Tool (RST) Reference</h2> |
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| <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> |
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| <h2>Disclaimer</h2> |
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| About the Catalog of Regulatory Science Tools |
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| 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. |
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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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