Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the Act).  Under section 520(f) of the Act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820.
The preamble describes the public comments received during the development of the QS regulation and describes the FDA Commissioner’s resolution of the comments. Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation.

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Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)