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February 20, 2019

The Future of Registries in the Era of Real-world Evidence for Medical Devices

Author Affiliations
  • 1National Evaluation System for Health Technology, Medical Device Innovation Consortium, Arlington, Virginia
  • 2American Medical Association, Chicago, Illinois
  • 3US Food and Drug Administration, Silver Spring, Maryland
JAMA Cardiol. 2019;4(3):197-198. doi:10.1001/jamacardio.2018.4933

Device-specific and condition-specific registries have historically played an important role in generating clinical evidence on safety and effectiveness by collecting, curating, and analyzing data on medical technologies. Professional societies, patient foundations, device manufacturers, and health systems develop registries for a variety of purposes, including clinical research, safety surveillance, quality measurement, and benchmarking. Evidence from registries such as the National Cardiovascular Data Registry has increasingly been used to support regulatory approvals by the US Food and Drug Administration’s Center for Devices and Radiological Health. More recently, active surveillance tools have been deployed in registries to detect safety signals.1