21 CFR 820 – This term refers to the FDA’s quality system regulation, which is issued under Title 21 of the Code of Federal Regulations. It outlines the minimum requirements for medical device design, development, testing, production, and installation in order to ensure safety and efficacy of the product. The regulation also includes guidance on maintaining documentation, validation processes, corrective and preventive actions, and more. With this regulation in place, manufacturers can ensure their products meet standards for quality and patient safety.