Between 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval using the Food and Drug Administration's premarket approval pathway, which only requires a single study to prove their safety and efficacy.
Nearly all of those 28 devices were cleared after just two studies, and overall, three or fewer studies were conducted for nearly half of the devices, according to a paper published in the Journal of the American Medical Association.
"Medical device regulation in the U.S. is well-known to be more rigorous than in other parts of the world," senior author Joseph S. Ross, MD, senior author of the study, told Reuters Health, but said there had not been a comprehensive review of the evidence behind high-risk devices. "The difference is, in many European countries they have much better capacity to follow devices once they are in practice," Dr. Ross told Reuters Health. "They allow devices on the market quicker in the U.K., but follow the devices so they can observe them in practice."
In addition, five of the devices had no post-market studies conducted to evaluate them and ten were later recalled. Half of the studies did not compare the high-risk devices to preexisting ones.