Document Detail

FDA's perspectives on cardiovascular devices.
MedLine Citation:
PMID:  20559979     Owner:  NLM     Status:  MEDLINE    
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 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.
Eric A Chen; Sonna M Patel-Raman; Kathryn O'Callaghan; Matthew G Hillebrenner
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Publication Detail:
Type:  Journal Article; Review     Date:  2009-03-10
Journal Detail:
Title:  Journal of cardiovascular translational research     Volume:  2     ISSN:  1937-5395     ISO Abbreviation:  J Cardiovasc Transl Res     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2010-06-18     Completed Date:  2010-10-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101468585     Medline TA:  J Cardiovasc Transl Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  143-6     Citation Subset:  IM    
Center for Devices and Radiological Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-450 Room 220V, Rockville, MD 20850, USA.
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MeSH Terms
Cardiology / instrumentation*,  legislation & jurisprudence
Clinical Trials as Topic / legislation & jurisprudence
Consumer Product Safety / legislation & jurisprudence
Cooperative Behavior
Defibrillators, Implantable
Device Approval* / legislation & jurisprudence
Equipment Design
Equipment Safety
Evidence-Based Medicine
Government Regulation*
Guidelines as Topic
Health Policy*
Heart Valve Prosthesis
Heart-Assist Devices
Interdisciplinary Communication
Pacemaker, Artificial
Product Labeling
Prosthesis Design
Risk Assessment
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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