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FDA Issues Draft Guidance on Third Party Review of 510(k), EUA Submissions

NEW YORK – The US Food and Drug Administration this week issued a draft guidance on the third-party review program for 510(k) submissions and Emergency Use Authorizations.

The guidance is meant to supersede the FDA's 2020 guidance on the 510(k) Third Party Review Program to provide additional details on the program's early interaction process and to describe how third-party review may be used to review EUAs in future emergencies.

The FDA's Third Party Review Program uses outside organizations to conduct what the guidance said are intended to be "FDA-equivalent reviews of appropriate devices." The program has been used to review some 510(k) submissions but has historically seen little uptake from industry. Some commenters have observed that industry has been reluctant to pay additional fees for third-party review, particularly given past cases in which the FDA has demanded further scrutiny even after devices passed muster with third-party reviewers.

Third-party review could become more important if the FDA implements its proposed rule on the regulation of laboratory-developed tests. Some have raised concerns that the FDA does not have the resources needed to review the expected influx of LDTs, and the agency has suggested third-party review as a potential way of addressing this challenge.

The draft guidance highlights the need for third-party review organizations to interact with the FDA prior to and throughout the review process to aid in assessing device eligibility and identifying relevant issues and provides recommendations for how to best engage in the early interaction process.

The draft guidance also lays out the process the FDA plans to use for third-party review of EUAs in the case of future emergencies. According to the guidance, the agency will seek out and contract with third-party organizations with relevant expertise once the nature of the emergency is known. It will, at its discretion, forward EUA requests it deems appropriate to third-party organizations for review. Those third-party organizations will then work with the submitter to address any questions or deficiencies in their application and forward their recommendation to the FDA, which will conduct a final review and issue an EUA, if appropriate.

The draft guidance will be open for public comments until Feb. 20, 2024.