FDA Offers Guidelines for Third-Party EUA Review, Revises Third-Party 510(k) Review Guidance
January 18, 2024 at 10:38 AM EST
In newly released draft guidance, the FDA presents its current thinking on third-party review of premarket notification (510(k)) submissions for medical devices. The draft guidance, “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review,” also provides the agency’s recommendations for third-party review of emergency use authorization (EUA) ... Read More
