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Posts published in “Guidance”

US – Updated Guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff

US – Updated Guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug…

Several revised or updates USFDA guidance

9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food…