Categorization

Prostheses are categorized as medical devices by the United States Food and Drug Administration (US FDA) and the European Commission (CE marking). The US FDA exempts suppliers of prostheses from pre-market notification [510(k)] but requires them to follow a Quality System Regulation (QSR) [or the Current Good Manufacturing Practice (CGMP), or a section of the United States Code of Federal Regulations (CFR) (21 CFR 820)]. 139

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