Because "experience has shown that the full magnitude of some potential risks don't always emerge during the mandatory clinical trials" required for the approval of medical devices, the Food and Drug Administration has launched a new Web page designed to inform the public on post-approval studies.
Currently, there are 44 records posted, covering such items as carotid stent systems, ceramic hips, cochlear implant systems and silicone breast implants. Posted on the Web page is information on FDA-ordered post-approval device studies conducted since Jan. 1, 2005. Listings include company and product names, approval number and date, and a description of the study.
"Electronic access will give the public an opportunity to see progress being made on a company's post-market commitments," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health in a news release.