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Viewpoint |

Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks

Mitchell W. Krucoff, MD1; Art Sedrakyan, MD, PhD2; Sharon-Lise T. Normand, PhD3,4
[+] Author Affiliations
1Division of Cardiology, Department of Medicine, Duke UniversityMedical Center, Durham, North Carolina
2MDEpiNet Science and Infrastructure Center, Weill Cornell Medical College, New York, New York
3Harvard T. H. Chan School of Public Health, Boston, Massachusetts
4MDEpiNet Methodology Center, Harvard Medical School, Boston, Massachusetts
JAMA. 2015;314(16):1691-1692. doi:10.1001/jama.2015.11036.
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This Viewpoint proposes implementation of strategic coordinated registries networks as the foundation for a national surveillance system that inform decisions about medical device safety, effectiveness, and quality.

In June 2014, the Medical Device Epidemiology Network (MDEpiNet) Public Private Partnership,1 on behalf of the US Food and Drug Administration Center for Devices and Radiologic Health (CDRH), convened the Medical Device Registries Task Force (MDRTF) (see eAppendix in the Supplement). The task force was launched to address the CDRH’s commitments2,3 to strengthen the medical device postmarket surveillance system using existing resources and under current authorities and to develop an integrated system that efficiently and effectively achieves its basic functions, from timely identification of postmarket signals to facilitating premarket device clearance and approval.

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