Zdrowie i gospodarka · 21/12/2023

FDA Releases Draft Guidance for 510(k) Third Party Review Program and EUA Review Process

The Food and Drug Administration (FDA) has released a draft guidance document outlining its 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review process, which allows third-party organizations to assist the FDA in reviewing 510(k) submissions and EUA requests in a timely manner.