GAO issues report on FDA postmarket studies on medical devices

Editor's Note

More than half (56%) of 313 medical device postapproval studies ordered by the Food and Drug Administration (FDA) from January 1, 2007, through February 23, 2015, were for cardiovascular devices, and most are making adequate progress, according to a Government Accountability Office (GAO) report. Postapproval studies are ordered to obtain additional information not available before devices are marketed, such as a device’s performance long term.

A total of 90% of 392 medical device postmarket surveillance studies ordered by the FDA from May 1, 2008, through February 24, 2015, were for orthopedic devices and implantable surgical mesh. Unlike postapproval studies, the FDA orders postmarket surveillance studies after a device is approved or cleared for marketing—for example, if the agency becomes aware of potential safety issues. 

Ninety percent of the 392 medical device postmarket surveillance studies FDA ordered from May 1, 2008, through February 24, 2015, were for orthopedic devices and devices such as certain kinds of implantable surgical mesh following concerns with these types of devices, and many were consolidated into ongoing studies.