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Tag: ISO 10993-1 FDA

Flash NewsFDA Compliance

Your Test Report Is Current. Is the Standard Behind It Still Current?

TL;DR What FDA Changed FDA’s Recognition List Number 066 modifies the list of voluntary consensus standards it recognizes for use in medical-device regulatory work. The Federal Register notice explains that manufacturers may use recognized standards and declarations of conformity to help address certain premarket requirements. CDRH listed the update among…

byGRC Times
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