Summary
US medical device regime: classification (I/II/III), 510(k)/PMA clearance, establishment registration, QSR cGMP, labelling.
Scope
Applies to medical devices marketed in the US (21 U.S.C. 360c). Requires: establishment registration & device listing (21 CFR 807), premarket notification 510(k) or PMA for Class II/III, quality system regulation (21 CFR 820), labelling (21 CFR 801).
Expert analysis
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