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Research Letter
Health Care Policy and Law
October 12, 2020

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

Author Affiliations
  • 1Yale School of Medicine, New Haven, Connecticut
  • 2San Francisco Veterans Affairs Medical Center, San Francisco, California
  • 3Department of Medicine, University of California School of Medicine, San Francisco
  • 4Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut
  • 5Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
  • 6Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 7Department of Otolaryngology–Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston
  • 8Harvard Business School, Boston, Massachusetts
JAMA Intern Med. Published online October 12, 2020. doi:10.1001/jamainternmed.2020.3214

In 1997, US Congress established the US Food and Drug Administration (FDA) De Novo premarket review pathway for novel low-risk and moderate-risk medical devices.1 In recent years, the FDA and medical device manufacturers have increasingly used the De Novo pathway; the FDA cleared 65 devices via this pathway between 1997 and 2012 and an additional 187 between 2013 and 2019.2-4 Devices cleared through the De Novo pathway represent novel technologies, and approval may serve as the basis for subsequent clearance of devices through the 510(k) pathway.5 The 510(k) pathway requires manufacturers to demonstrate that new devices are “substantially” equivalent to previously cleared devices, typically without clinical studies demonstrating safety or effectiveness. This study characterizes the premarket clinical evidence supporting clearance of moderate-risk therapeutic devices cleared through the De Novo pathway and postmarket experience, including FDA-required postmarket studies, recalls, and subsequent 510(k) clearances.

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