[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Views 348
Citations 0
Research Letter
August 2016

Availability and Dissemination of Results From US Food and Drug Administration–Mandated Postapproval Studies for Medical Devices

Author Affiliations
  • 1University of California San Francisco, San Francisco
  • 2Wellesley College, Wellesley, Massachusetts
JAMA Intern Med. 2016;176(8):1221-1223. doi:10.1001/jamainternmed.2016.2955

Medical devices present unique challenges to the US Food and Drug Administration (FDA) approval process owing to their complexity, the learning curve associated with adopting new technology, and short market life compared with drugs.1 In 2011 the Institute of Medicine recommended a lifecycle approach highlighting the importance of postapproval studies (PAS).2 In its efforts to speed patient access to potentially life-saving medical devices, the FDA has been shifting priorities from premarket to postmarket data collection.3 Thus, it is important to understand how well PAS are doing at achieving the agency’s goals of assessing safety and effectiveness.46 Publication is the best method for dissemination of results to inform clinical practice and provide data transparency. We evaluated the availability of results of completed PAS, including publication in peer-reviewed journals, labeling, or posting on company websites.

First Page Preview View Large
First page PDF preview
First page PDF preview