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OGC-97-3 1 (1996-10-24)

handle is hein.gao/gaobabloz0001 and id is 1 raw text is: GAO United States General Accounting Office Washington, D.C. 20548 Office of the General Counsel B-275070 October 24, 1996 The Honorable Nancy Landon Kassebaum Chairman The Honorable Edward M. Kennedy Ranking Minority Member Committee on Labor and Human Resources United States Senate The Honorable Thomas J. Bliley, Jr. Chairman The Honorable John D. Dingell Ranking Minority Member Committee on Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by Department of Health and Human Services, Food and Drug Administration, entitled Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation (RIN: 0910-AA09). We received the rule on October, 11, 1996. It was published in the Federal Register as a final rule on October 7, 1996. 61 Fed. Reg. 52601. The final rule revises existing current good manufacturing practice requirements for medical devices and incorporates 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. The rule adds preproduction design controls and is intended to achieve consistency with quality system requirements worldwide. GAO/OGC-97-3

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