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Research Letter
March 30, 2020

Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices

Author Affiliations
  • 1Division of Cardiology, New York University, New York
  • 2UCSF School of Medicine, University of California, San Francisco
  • 3Division of Cardiology, UCSF School of Medicine, University of California, San Francisco
  • 4Editor, JAMA Internal Medicine
JAMA Intern Med. 2020;180(5):801-803. doi:10.1001/jamainternmed.2020.0297

The US Food and Drug Administration (FDA) requires that high-risk (class III) medical devices undergo premarket approval (PMA) review, the most stringent path through which devices enter the market. Since 1994, in an effort to enable breakthrough technology to reach market faster, the FDA has also offered priority review.1 There is a paucity of data on the speed and effectiveness of regulatory review in these expedited pathways.2 We compared priority vs standard PMA review with regard to review times, device recalls, and adverse events.

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