title: FDA regulation of cardiovascular devices and opportunities for improvement.
abstract: Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA's pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University of California, Davis, CA, USA.
authors.forename: Sanket S
authors.initials: SS
authors.lastname: Dhruva
authors.forename: Rita F
authors.initials: RF
authors.lastname: Redberg
mesh_terms: D002309:Cardiology / Q000295:instrumentation*; D002318:Cardiovascular Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic; D017147:Defibrillators, Implantable; D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety / Q000639:trends; D049673:History, 20th Century; D006801:Humans; D062307:Medical Device Legislation / Q000266:history; D057052:Medical Device Recalls; D010138:Pacemaker, Artificial; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history; D014656:Vascular Surgical Procedures / Q000295:instrumentation*