FDA and the medical device industry: hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, March 25 and June 3, 1992, Volume 4
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, 1992 - Political Science - 297 pages
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Agency Andersen applications approval process audits Benson bioresearch monitoring breast implants CDRH Chairman Chelimsky class III devices clinical trials Compliance and Surveillance concerns conducted Damaska decision Device Evaluation device manufacturers Dingell Director District Office Division documents Dorney employees ensure facility fact FDA inspector FDA's firm Food and Drug GMP inspections GMP regulation GMP violations going Hooten implants implementation indicated Integrity Officer investigation Investigational Device Exemptions issues Johnson laser latex look manufacturing practices March 25 medical device NOTIFIED ODE management Office of Device ophthalmologist Orcolon Oversight percent pre-Amendments premarket approval problems procedures quality assurance question questionnaire radiation radiation therapy recall recommendations regulatory response review process Rowland safety and effectiveness specific Subcommittee staff submissions submitted substantial equivalence tensile tensile strength Therac 25 Theratronics tion wire