title: The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices.
authors.forename: W
authors.initials: W
authors.lastname: Sapirstein
authors.forename: S
authors.initials: S
authors.lastname: Alpert
authors.forename: T J
authors.initials: TJ
authors.lastname: Callahan
mesh_terms: D017277:Drug Approval; D004864:Equipment and Supplies; D006350:Heart Valve Prosthesis; D006801:Humans; D007880:Legislation, Drug; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration