Too little research backs high-risk medical devices

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...