Designing trials for testing prosthetic cardiac valves: a Food and Drug Administration perspective.
Sapirstein
W
W
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD 20850, USA. wys@cdrh.fda.gov
D002986:Clinical Trials as Topic / Q000379:methods*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration