title: FDA's revitalization of medical device review and regulation.
authors.affiliation: AAMI/NIH Cardiovascular Science and Technology Conference, Rockville, Maryland.
authors.forename: D A
authors.initials: DA
authors.lastname: Kessler
mesh_terms: D002986:Clinical Trials as Topic; D004493:Education; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D008422:Materials Testing; D011050:Policy Making; D011358:Product Surveillance, Postmarketing; D011640:Public Policy; D012106:Research; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration