New FDA Draft Guidance Addresses 510(k) Third-Party Review Program and Third-Party EUA Review

The Food and Drug Administration issued a new draft guidance for industry on Dec. 21 that outlines the agency’s current thinking on key aspects of the 510(k) Third-Party Review Program (3P510k) and third-party review of emergency use authorization (3PEUA) requests. The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist the agency in reviewing in a timely manner.

In the guidance, FDA seeks to address the following objectives: 

• To describe and distinguish FDA’s expectations for the 3P510k Review Program and for 3PEUA review.
• To describe the factors FDA will use in determining device type eligibility for review by 3P510k review organizations.
• To outline FDA’s process for the recognition, rerecognition, suspension and withdrawal of recognition for 3P510k review organizations.
• To 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.
• To outline FDA’s expectations to prevent conflicts of interest between the third-party review organizations and other entities.
• To describe FDA’s expectations regarding recordkeeping for the compensation process between the third-party review organization(s) and other entities.

FDA emphasized that the draft guidance is not final and available for comment purposes only. Those interested in submitting comments on the guidance may do so through Feb. 20. Submission instructions are available in the Federal Register notice.

When final, the draft guidance will supersede the March 2020 guidance “510(k) Third-Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations.”