The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the U.S. Food, Drug and Cosmetic (FD&C) Act. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

The QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

The QS Regulation is contained in Title 21 Part 820 of the Code of Federal Regulations. This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records.

The designation of a device as a "custom" or "customized" device does not confer a GMP exemption. Establishments Subject to the GMP include Custom Device Manufacturers and Contract Manufacturers. Contract manufacturers and specification developers shall comply with the sections of the QS regulation that apply to the functions they perform.