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# 510(k) Third Party Review EUA Guidance
- URL: https://www.fdaweb.com/510-k-third-party-review-eua-guidance/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156054

FDA has published a draft guidance, *510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review*. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review?ref=fdaweb.com) says FDA may contract with third-party review organizations to perform reviews of emergency use authorization (EUA) requests when appropriate emergency declaration authorities are active.

The guidance says its objectives are to:

- describe and distinguish FDA’s expectations for the third-party 510(k) review program (3P510k) and for third-party EUA (3PEUA) review;
- describe the factors FDA will use in determining device type eligibility for review by 3P510k review organizations;
- outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k review organizations;
- clarify the agency’s expectations for review under both 3P510k review and 3PEUA review for all stakeholders to ensure confidence and consistent quality of work by third-party review organizations to eliminate the need for routine, substantive re-review by FDA;
- outline FDA’s expectations to prevent conflict of interest between the third-party review organization and other entities; and
- describe FDA’s expectations regarding the compensation process between the third-party review organization(s) and other entities.