Many High-Risk Medical Devices Get FDA Approval With Only A Single Trial: Study.

Five devices had no postmarket studies, and 13 others had three or fewer postmarket studies. Half of the studies did not compare the new device to an existing one. “I don’t want to scare the public,” but these results should inform ongoing regulation and legislation for policymakers, Ross said. “We certainly have evidence of where devices have had safety problems and it’s taken us too long as a country to identify those problems,” said Dr. Josh Rising, director of health care programs at the Pew Charitable Trusts, who was not part of the new study. He cited metal-on-metal hip implants, which are not high-risk medical devices. They may damage the bone or tissue of the hip over time. The U.K., Canada and Australia all noticed this problem and issued medical alerts between 2010 and 2012. The FDA issued a similar safety communication in January of 2013. “Medical devices vary so much, in what they are and what they do, there’s not a one size fits all policy,” Rising said. “The FDA needs to look at each device that comes through and assess what’s going to be needed.” http://www.reuters.com/article/2015/08/11/us-health-regulation-device-safety-idUSKCN0QG1PQ20150811