Cardiovascular device development: an FDA perspective.
Zuckerman
Bram D
BD
Division of Cardiovascular & Respiratory Devices, U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA. bdz@cdrh.fda.gov
Muni
Neal I
NI
D002309:Cardiology / Q000295:instrumentation*; D018795:Device Approval / Q000592:standards; D006801:Humans; D019736:Prostheses and Implants / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*