title: Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?
abstract: The regulatory processes by which industry obtains approval for marketing and sales of medical devices from the United States Food and Drug Administration is distinct from the drug approval pathways, poorly understood by clinicians, and widely criticized by clinical investigators and industrial sponsors of new technology. This paper reviews the most common pathways for obtaining such approval for endovascular devices used in the treatment of peripheral arterial disease. Unique issues pertinent to clinical trials carried out in this area are highlighted. Future directions for evolution of the regulatory process consonant with the mandated requirements for demonstration of safety and efficacy are discussed.
authors.affiliation: Division of Cardiology, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY 10032, USA. jzw1@columbia.edu
authors.forename: Judah
authors.initials: J
authors.lastname: Weinberger
authors.forename: John H
authors.initials: JH
authors.lastname: Rundback
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Ratchford
mesh_terms: D000800:Angioplasty, Balloon / Q000295:instrumentation; D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D016491:Peripheral Vascular Diseases / Q000628:therapy; D017410:Practice Guidelines as Topic; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration; D014656:Vascular Surgical Procedures / Q000295:instrumentation*