The U.S. Food and Drug Administration (FDA) has published its final guidance on its third-party review program and its third-party emergency use authorization (EUA) review process.
The final guidance, titled “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review,” provides manufacturers with updated information on the use of qualified third parties to conduct an initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the FDA’s third-party review program. In brief, the guidance addresses:
- The factors the FDA will use in determining device eligibility for review by third parties
- The process for recognition, re-recognition, suspension, and withdrawal of recognition for certain 510(k) reviews
- The FDA’s expectations for third-party reviews to ensure confidence and consistent quality of work by third-party review organizations
- The FDA’s expectations to prevent conflicts of interest between third-party review organizations and other entities
- The FDA’s expectations regarding the compensation process between third-party review organizations and other entities.
The final guidance document on the FDA’s third-party review program and emergency use authorization review process is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review.
