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 Center for Devices Chairman Chelimsky Class III devices clinical trials Compliance and Surveillance concerns conducted corrective action Damaska decisions determine Device Evaluation Devices and Radiological Dingell Director District Office Division documents Dorney employees ensure facility fact FDA inspector FDA's firm Food and Drug glaucoma GMP inspections GMP regulation GMP violations going heart wires Hooten identified implants implemented indicated Integrity Officer investigational device exemptions issues Johnson laser latex look manufacturing practices March 25 medical device MEDTRONIC NOTIFIED ODE managers Office of Device ophthalmologist Orcolon percent pre-Amendments premarket approval problems procedures quality assurance questions radiation recall recommendations regulatory response review process Rowland safety and effectiveness specific Subcommittee staff submissions submitted substantial equivalence tensile strength testing Theratronics tion