title: FDA's perspectives on cardiovascular devices.
abstract: The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-450 Room 220V, Rockville, MD 20850, USA. eric.chen@fda.hhs.gov
authors.forename: Eric A
authors.initials: EA
authors.lastname: Chen
authors.forename: Sonna M
authors.initials: SM
authors.lastname: Patel-Raman
authors.forename: Kathryn
authors.initials: K
authors.lastname: O'Callaghan
authors.forename: Matthew G
authors.initials: MG
authors.lastname: Hillebrenner
mesh_terms: D000818:Animals; D002309:Cardiology / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D003299:Cooperative Behavior; D017147:Defibrillators, Implantable; D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design; D004869:Equipment Safety; D019317:Evidence-Based Medicine; D033161:Government Regulation; D017408:Guidelines as Topic; D006291:Health Policy; D006350:Heart Valve Prosthesis; D006353:Heart-Assist Devices; D006801:Humans; D033183:Interdisciplinary Communication; D010138:Pacemaker, Artificial; D011356:Product Labeling; D011474:Prosthesis Design; D018570:Risk Assessment; D014481:United States