FDA and the Medical Device Industry: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, 102nd Congress, 2nd Session, March 25 and June 3, 1992
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, 1992 - Health & Fitness - 297 pages
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action Agency Andersen applications approval process Benson bioresearch monitoring breast implants CDRH Center for Devices Chairman Chelimsky class III devices clinical trials Compliance and Surveillance concerns conducted correct Damaska Device Evaluation device manufacturers Devices and Radiological Dingell Director District Office Division Dorney employees facility fact FDA inspector FDA's firm Food and Drug GMP compliance GMP inspections GMP regulation GMP violations going Hooten implants implementation indicated inspec investigational device exemption issue Johnson laser latex look manufacturing practices March 25 medical device notification ODE management Office of Device ophthalmologist Orcolon percent pre-Amendments premarket approval problems procedures quality assurance question questionnaire radiation recall recommendations regulatory response review process Rowland safety and effectiveness Subcommittee staff submitted substantial equivalence tensile strength Therac 25 Theratronics tion X)OTS