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FDA Aims To Reduce 510(k) Review Times With New Submission Acceptance Process

Draft guidance outlines criteria that 510(k) submissions must meet before the agency begins its substantive review.

FDA is proposing new acceptance criteria for 510(k) submissions with the goal of improving overall review times and enhancing the quality of submissions.

A draft guidance released Aug. 10, “Refuse to Accept Policy for 510(k)s,” modifies guidances from 1993 and 1994...

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