The U.S. Food and Drug Administration's Premarket Approval pathway allows high-risk medical devices on the market with only one study to prove their safety and effectiveness, and there are a limited number of studies done post-market, according to research published in Journal of the American Medical Association.
Medical device regulation in the U.S. is more rigorous than in other parts of the world, but "the difference is, in many European countries they have much better capacity to follow devices once they are in practice," senior author Joseph S. Ross, M.D., of the Yale University School of Medicine, told Reuters.
Researchers, using ClinicalTrials.gov, looked at research on 28 high-risk therapeutic devices that received initial marketing approval via the Premarket Approval pathway during 2010 and 2011. Of those devices, 15 were new stents for the heart or other parts of the body; 10 were later recalled from the market.
The FDA relied on roughly one study per device to determine market approval, and there were 33 FDA-required postmarket studies for the 28 devices, according to Reuters. Only six of those required studies had been completed by October 2014, Ross and his colleagues found.
Five devices had no postmarket studies, and 13 others had three or fewer postmarket studies. In addition, half of the studies did not compare a new device to an existing one.
The 21st Century Cures Act, which aims to streamline development and evaluation of new drugs and devices, has drawn criticism for proposing to redefine the evidence on which high-risk devices can be approved to include case studies, registries and journal articles rather than more rigorous clinical trials.
The Reuters article points out that having device information in searchable records, which isn't available today, would make post-market studies easier.
The FDA's plan for a Unique Device Identifier (UDI) system, however, represents a "landmark step" toward that goal, according to the Brookings Institution.
To learn more:
- read the study abstract
- here's the Reuters article