Reauthorization of the Medical Device User Fee and Modernization Act: Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, First Session, May 16, 2007, Volume 4
U.S. Government Printing Office, Jan 1, 2008 - Medical instruments and apparatus industry - 150 pages
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additional adverse event agency application fees appropriate breast implants budget authority CAPPS CDRH Chairman clinical trials committee consumer Dalkon Shield device manufacturers device program Device User Fee Devices and Radiological DIANA DEGETTE Dorman ensure ESHOO FDA Alliance FDA's Fee and Modernization Food and Drug FRANK PALLONE funding healthcare hospitals important improve increase innovation interactive review Investigational Device Exemption LAVIOLETTE legislation LOIS CAPPS MDMA MDUFMA II medical device industry medical device safety Medical Device User medical technology MedSun million Modernization Act NATHAN DEAL opening statement PALLONE patient safety pediatric device pediatric medical device percent performance goals post-market safety post-market studies post-market surveillance pre-market pre-market approval proposed recommendations regulation regulatory reprocessed review process risks safe and effective SCHULTZ SHADEGG SHUREN small businesses staff Thank Third Party Inspection toxic shock syndrome user fee program WAXMAN ZUCKERMAN