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July 17, 2013

The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance

Author Affiliations
  • 1Department of Public Health and Cardiac Surgery, Weill Cornell Medical College, Cornell University, New York, New York
  • 2Division of Epidemiology, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
  • 3Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
JAMA. 2013;310(3):257-259. doi:10.1001/jama.2013.7133

Since the creation of the US Food and Drug Administration (FDA) Medical Device Epidemiology Network (MDEpiNet),1 there has been an increasing FDA commitment to support the development of a global medical device research and surveillance infrastructure. The FDA’s new postmarket surveillance plan2 strengthens this commitment and highlights the importance of national and international registries, and multi-stakeholder involvement for ensuring this commitment is fulfilled. This Viewpoint summarizes the potential for development of an International Consortium of Cardiovascular Registries, modeled on a consortium established for orthopedic devices, as an initial project in the realm of cardiovascular devices with the focus on transcatheter aortic valve replacement (TAVR).

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