Medical device amendments, 1973: Hearings, Ninety-third Congress, first session, on S. 2368 ...
U.S. Govt. Print. Off., 1974 - Medical - 1184 pages
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Goldhammer Gilbert S consultant to the Subcommittee on Intergovern
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AAMI adequate advertising agency Alka-Seltzer amended American Dental American Dental Association application appropriate approval Beall bill Biomedical Engineering C. R. Bard cardiac pacemakers Chairman classification clinical reagents companies complications consumer Cosmetic Act Court Dalkon Shield defect Dental Materials device standards Drug Administration established evaluation exemption experience Federal Food Food and Drug hazard heart valves hospital implanted industry inserting Institute intrauterine devices investigation IUD's labeling Laboratories manufacturing practices Materials and Devices medical device legislation Medtronic ment mitral valve mitral valve replacement National organizations pacemakers panels paragraph patient person physicians premarket clearance problems procedures promulgated proposed prosthesis public health pursuant Pyrolite recommendations regulation regulatory representatives safe safety and effectiveness scientific review Secretary section 513 Senator Kennedy September 17 specific struts Subcommittee subsection Teflon testing thereof tion Travenol