21 CFR Part 820 is the FDA Current Good Manufacturing Practice (CGMP) regulation which became effective on December 18, 1978. The regulations ensure that medical devices distributed in the US market are designed and developed with adequate procedures, people are trained, and quality records are maintained. In 1990, the FDA revised of the CGMP regulation to add the requirement for design controls (i.e., 21 CFR 820.30) authorized by the Safe Medical Devices Act. The revised regulation was released in 1996, and it is referred to as the Quality System Regulations (i.e., QSR). Title 21 is the section of the Code of Federal Regulations (i.e., CFR) reserved for the Food and Drug Administration (i.e., FDA) regulations.

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