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# FDA Draft Guide on 510(k) 3rd-party Reviews
- URL: https://www.fdaweb.com/fda-draft-guide-on-510-k-3rd-party-reviews/
- Published: 2016-09-09T12:00:00.000Z
- Updated: 2026-09-14T21:30:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136761

FDA has released a [draft guidance ](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339697.pdf?ref=fdaweb.com)on “510(k) Third Party Review Program” that describes harmonization efforts, such as incorporating elements from the Medical Device Single Audit Program into the third-party review program. The document also discusses third-party reviewers’ applications for initial recognition into the program. Under the program, recognized third parties can conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices. It is intended to provide manufacturers of these devices an alternative review process that may yield more rapid 510(k) decisions, according to the guidance. The third parties forward their reviews, recommendations, and 510(k) submissions to FDA for a final decision on substantial equivalence.