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# Third-Party Review Guidance
- URL: https://www.fdaweb.com/third-party-review-guidance/
- Published: 2024-11-20T12:00:00.000Z
- Updated: 2026-09-14T14:47:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158227

FDA has published a guidance, *510(k) Third-Party Review Program and Third-Party Emergency Use Authorization (EUA) Review*, with information on the two programs. 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 the guidance’s objectives are to:

- describe and distinguish FDA’s expectations for the 3P510k review program and 3PEUA review;
- the factors FDA will use in determining device type eligibility for review by 3P510 ROs (review organizations);
- outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k ROs;
- clarify FDA’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 conflicts of interest between the third-party review organization(s) and other entities; and
- describe FDA’s expectations regarding the compensation process between the third-party review organization(s) and other entities.

The guidance contains an Introduction, Background, Scope, Definitions, Third-Party Review of 510(k) Submissions and EUA Requests, and the Paperwork Reduction Act of 1995.