Medical Device Safety: Hearings Before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, on H.R. 3095 ... November 6, 1989 and July 17, 1990
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
U.S. Government Printing Office, 1990 - Medical instruments and apparatus - 260 pages
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action adverse Aequi Aequitron Agency apnea monitor associated assurance believe Benson bill Bowsher Chairman Chelimsky class III devices CLMA Comdisco complaints compliance concern Congress contact lenses Cosmetic Act Dannemeyer Davis DEFIBRILLATOR determinations device manufacturers device problems device reporting regulation diagnostic evaluation FDA's Federal Food FIRM Food and Drug GERRY SIKORSKI heart valves HEMOPERFUSION HIMA hospitals implant implementation inserting in lieu inspection issue Kusserow legislation lens mandatory manufacturer's manufacturing practices Medical Device Amendments medical device recalls medical device reporting Nielson notification paragraph patients percent performance standards PLASMAPHERESIS postmarket surveillance system premarket approval premarket review problem reports public health question recommendations record regulatory report to FDA reporting requirements risk Rowland safety and effectiveness Secretary serious injury Sikorski statement subcommittee submitted subsection substantial equivalence testimony testing Thank tion underreporting Wavell Waxman Wisler