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Research Letter
October 2018

Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program

Author Affiliations
  • 1University of California, San Francisco School of Medicine, San Francisco
  • 2Robert Wood Johnson Foundation Clinical Scholars Program, Yale University School of Medicine, New Haven, Connecticut
  • 3Veterans Affairs Connecticut Healthcare System, New Haven, Connecticut
  • 4Division of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco
  • 5Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco School of Medicine, San Francisco
  • 6Editor, JAMA Internal Medicine
JAMA Intern Med. 2018;178(10):1418-1420. doi:10.1001/jamainternmed.2018.3649

This study evaluates the randomized clinical trials conducted to provide evidence of the safety and effectiveness of cardiovascular devices approved by the Food and Drug Administration (FDA). The FDA approves high-risk devices through premarket approval if it determines the device provides reasonable assurance of safety and effectiveness. The dual goals of this approval process are to ensure patient safety and facilitate access to beneficial technologies. For the past several decades, priority review mandated by legislation has intended to hasten FDA approval, whereby an application receives precedence in review and additional review resources, if needed. The 21st Century Cures Act of 2016 introduced the Breakthrough Devices program, an initiative that is built on but supersedes another program known as Priority Review. Under Breakthrough Devices, the FDA “may accept a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors […] and adequate postmarket controls to support premarket approval.”1 The quality of evidence required for cardiovascular devices to be approved under Priority Review is not known.

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