October 27, 2015

Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks

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

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(16):1691-1692. doi:10.1001/jama.2015.11036

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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