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What are FDA's cGMP requirements for medical devices?
FDA's cGMP requirements for devices are set forth in the quality system regulation (21 CFR Part 820). The requirements govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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