GAO, Noting Morcellator Issues, Tells FDA To Step Up Device Surveillance
February 14, 2017
Congress' investigative arm is pressing FDA to improve its surveillance of marketed medical devices, pointing to problems that led the agency to warn against use of laparoscopic power morcellators in minimally invasive surgeries. Agency officials told congressional investigators there are weaknesses in the current passive surveillance approach and the enforcement focus on device makers, noting FDA is working to get better information from hospitals and to collect real-world evidence through its evolving National Evaluation System. The Government Accountability Office, in...
Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting as the Trump administration and congressional Republicans look to their next steps following the collapse of their efforts to repeal and replace.