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FDA publishes a new draft guidance on 510(k) Third Party Review Program

By January 3, 2024No Comments

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA requests by third party review organizations. This draft guidance provides updated recommendations on the 510(k) Third party Review Program previously discussed in the 2020 final guidance, “510(k) Third Party Review Program.” The 2020 final guidance remains in effect until this draft guidance is finalized.