Tag: FDA device classification

Medical Device Registration & Listing Compliance – XPRO AMERICA

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All medical device manufacturers, repackers, relabelers, specification developers, and initial importers must comply with FDA regulations for establishment registration and device listing under 21 CFR Part 807. Annual registration ensures…

De Novo Device Classification & FDA Support – XPRO AMERICA

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The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain…