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# Guidance on 510(k) Third-party Reviews
- URL: https://www.fdaweb.com/guidance-on-510-k-third-party-reviews/
- Published: 2016-09-12T12:00:00.000Z
- Updated: 2026-09-14T21:30:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Devices, #legacy-id-D5136777

*Federal Register* notice: FDA has released a draft guidance on “510(k) Third Party Review Program” that provides current thinking and proposes to harmonize with elements from the International Medical Device Regulators Forum’s regulatory assessment program called the Medical Device Single Audit Program. In addition, it describes criteria to reaccredit and deny reaccreditation of third-party review organizations. To view the guidance, click [here](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339697.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-12/pdf/2016-21876.pdf?ref=fdaweb.com).