Manufacturers of medical devices must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated medical 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. Please include the following seven (7) subsystems in your Quality Management System (QMS) manual: - Management Subsystem - Corrective and Preventive Action Subsystem - Production & Process Control Subsystem - Documents, Records and Change Control Subsystem - Design Controls Subsystem - Materials Controls Subsystem