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).
Art Sedrakyan, Danica Marinac-Dabic, David R. Holmes. The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance. JAMA. 2013;310(3):257–259. doi:10.1001/jama.2013.7133