Medical Devices Current Good Manufacturing Practice Final Rule and Quality System Regulation

OGC-97-3: Published: Oct 24, 1996. Publicly Released: Oct 24, 1996.


Additional Materials:


Office of Public Affairs
(202) 512-4800

Pursuant to a legislative requirement, GAO reviewed the Food and Drug Administration's (FDA) new rule on current good manufacturing practices for and quality system regulation of medical devices. GAO found that: (1) the rule would revise existing current good manufacturing practice requirements for medical devices and incorporate them into a quality system regulation which includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, installing, and servicing medical devices intended for human use; (2) the rule is intended to achieve consistency with quality system requirements worldwide; and (3) FDA complied with applicable requirements in promulgating the rule.

Dec 1, 2020

Nov 30, 2020

Nov 18, 2020

Nov 17, 2020

Nov 13, 2020

Nov 12, 2020

Nov 4, 2020

Oct 26, 2020

Looking for more? Browse all our products here