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GUIDANCE DOCUMENT

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations November 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-2565
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations. This guidance provides updated recommendations on the 510(k) Third Party Review Program and supersedes the "510(k) Third Party Review Program" guidance.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-2565.

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