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

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


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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.

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