What is 21CFR820?

21 CFR Part 820, also known as the Quality System (QS) regulation, is a regulation promulgated by the United States Food and Drug Administration (FDA) that governs 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. It outlines current good manufacturing practice (CGMP) requirements. Compliance with 21 CFR Part 820 is mandatory for medical device manufacturers who wish to sell their products in the United States. It helps to ensure that medical devices are safe and effective for their intended use.