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The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance

The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance Opinion The International Registry Infrastructure VIEWPOINT for Cardiovascular Device Evaluation and Surveillance Since the creation of the US Food and Drug Adminis- tive merits of TAVR and surgical aortic valve replace- ArtSedrakyan,MD,PhD Department of Public tration (FDA) Medical Device Epidemiology Network ment. These and other questions remain unresolved for Health and Cardiac (MDEpiNet), there has been an increasing FDA com- anumberofreasons,includinglimitedavailabledata,dif- Surgery, Weill Cornell mitment to support the development of a global medi- ferent patient populations, limited ascertainment of in- Medical College, cal device research and surveillance infrastructure. The frequentcomplications,lackofcommondefinitions,and Cornell University, New York, New York. FDA’snewpostmarketsurveillanceplan strengthensthis rapidly iterative devices. commitment and highlights the importance of national Prior to consideration of FDA approval, the “ratio- Danica Marinac-Dabic, and international registries, and multi-stakeholder in- nal dispersion” of this novel technology into clinical prac- MD, PhD volvementforensuringthiscommitmentisfulfilled.This tice occupied a central position of concern. Starting in Division of Viewpointsummarizesthepotentialfordevelopmentof early 2011, the relationship of the FDA in concert with Epidemiology, Center for Devices and an International Consortium of Cardiovascular Regis- the American College of Cardiology National Cardiovas- Radiological Health, US tries, modeled on a consortium established for ortho- cular Device Registry and Society of Thoracic Surgeons Food and Drug pedic http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance

JAMA , Volume 310 (3) – Jul 17, 2013

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Publisher
American Medical Association
Copyright
Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2013.7133
pmid
23860981
Publisher site
See Article on Publisher Site

Abstract

Opinion The International Registry Infrastructure VIEWPOINT for Cardiovascular Device Evaluation and Surveillance Since the creation of the US Food and Drug Adminis- tive merits of TAVR and surgical aortic valve replace- ArtSedrakyan,MD,PhD Department of Public tration (FDA) Medical Device Epidemiology Network ment. These and other questions remain unresolved for Health and Cardiac (MDEpiNet), there has been an increasing FDA com- anumberofreasons,includinglimitedavailabledata,dif- Surgery, Weill Cornell mitment to support the development of a global medi- ferent patient populations, limited ascertainment of in- Medical College, cal device research and surveillance infrastructure. The frequentcomplications,lackofcommondefinitions,and Cornell University, New York, New York. FDA’snewpostmarketsurveillanceplan strengthensthis rapidly iterative devices. commitment and highlights the importance of national Prior to consideration of FDA approval, the “ratio- Danica Marinac-Dabic, and international registries, and multi-stakeholder in- nal dispersion” of this novel technology into clinical prac- MD, PhD volvementforensuringthiscommitmentisfulfilled.This tice occupied a central position of concern. Starting in Division of Viewpointsummarizesthepotentialfordevelopmentof early 2011, the relationship of the FDA in concert with Epidemiology, Center for Devices and an International Consortium of Cardiovascular Regis- the American College of Cardiology National Cardiovas- Radiological Health, US tries, modeled on a consortium established for ortho- cular Device Registry and Society of Thoracic Surgeons Food and Drug pedic

Journal

JAMAAmerican Medical Association

Published: Jul 17, 2013

References