Medical devices; current good manufacturing practice (CGMP) final fule; quality system regulation--FDA. Final rule.

The Food and Drug Administration (FDA) is revising the current good manufacturing practice (CGMP) requirements for medical devices and incorporating them into a quality system regulation. The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. This action is necessary to add preproduction design controls and to achieve consistency with quality system requirements worldwide. This regulation sets forth the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.