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GUIDANCE DOCUMENT

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations December 2023

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-2565
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by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 reviews of 510(k) submissions and EUA requests by third party review organizations. This draft guidance provides updated recommendations on the 510(k) Third party Review Program previously discussed in the 2020 final guidance, "510(k) Third Party Review Program." The 2020 final guidance remains in effect until this draft guidance is finalized. 


Submit Comments

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
Food and Drug Administration
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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