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Research Letter |

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

Odayme Quesada, MD1; Erin Yang, BS2; Rita F. Redberg, MD, MSc1
[+] 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.
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Published online


This study analyses the availability of results from postapproval studies of medical devices.

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.

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Medical Device Postapproval Study From Time of Study Completion to Publication Cox Model

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