title: Cardiovascular device development: an FDA perspective.
authors.affiliation: Division of Cardiovascular & Respiratory Devices, U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA. bdz@cdrh.fda.gov
authors.forename: Bram D
authors.initials: BD
authors.lastname: Zuckerman
authors.forename: Neal I
authors.initials: NI
authors.lastname: Muni
mesh_terms: 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*