The Medical Device Epidemiology Network Initiative (MDEpiNet) is part of the Epidemiology Research Program (ERP) at the FDA’s Center for Devices and Radiological Health (CDRH). The initiative is a collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed.
By bridging gaps in evidence, developing datasets and creating new methods of conducting robust analytic studies, MDEpiNet aims to develop new ways to study medical devices that improve the understanding of their safety and effectiveness throughout their life cycle.
CDRH is developing MDEpiNet in stages, with the expectation that it will ultimately become a self-sustaining, independent Public-Private Partnership between the FDA and participating partners. By providing more complete and accurate information on device use and performance, MDEpiNet will help the FDA, the medical device industry, medical professionals, and the American public make better, more informed health care decisions.
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Regulatory Science and Sustainable Implementation of National and International Medical Device Registries, March 24, 2014 Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) Enhancing post-market surveillance through developing registries for medical device epidemiology (U01)