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FDA Reattempts Guidance On Third-Party 510(k) Review Program

FDA is again attempting to outline its thinking on the 510(k) third-party review program in a new draft guidance. The program, which allows accredited organizations to conduct 510(k) reviews for certain products, has had a lackluster performance since it was first mandated by Congress in 1997.

FDA is making a renewed effort to issue guidance addressing the long-languishing 510(k) third-party review program. The agency has put out a second attempt at a draft guidance to modernize and globally harmonize the program after a first-attempt draft was issued in 2013.

Enacted in the FDA Modernization Act of 1997, the third-party review program, which allows accredited organizations to conduct 510(k) reviews for certain products, was intended to make the 510(k) program more efficient, but over the ensuing

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