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Comments on device test labs accreditation pilot program sought by FDA
5/17/2017

The FDA has issued a request for comments on its planned Accreditation Scheme for Conformity Assessment Pilot Program, which aims to accredit medical device test laboratories for manufacturers' conformity to consensus standards recognized by the agency to support premarket review. The program comes as part of the agency's MDUFA IV agreement with the industry and is expected to pilot by the end of fiscal 2020.

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