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CDRH Churning Out Inspection Guidances

CDRH has been busy getting inspection-related guidance documents ready. Last week it published the latest version of its general guidance document on inspections of medical device manufacturers. Today it published a draft guidance intended to help manufacturers prepare for FDA review of the manufacturing section of their PMAs, which includes an inspection.

A big problem since the advent of MDUFMA has been that all too often, when a PMA review is done quickly, the sponsor isn't ready for inspection. Let's hope this guidance makes that less common. Electronic comments on the draft guidance can be submitted here until September 18.

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