Drug & Device News

On Dec. 14, 2011, Senators Charles Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation in the U.S. Senate that would increase U.S. Food and Drug Administration (FDA) oversight of some medical implant products. If passed, the Medical Device Patient Safety Act would permit the FDA to better monitor the safety of implanted medical devices by requiring manufacturers to agree to collect post-market safety data as a condition of approval to market their devices to the public. While this type of data is currently required only of manufacturers of the highest-risk devices ' those that have been approved through the rigorous Pre-market Approval (PMA) process ' the new legislation would extend the agency's post-market surveillance powers to cover devices that have entered the market under the 510(k) system. (A device cleared under the 510(k) system must be shown to be substantially equivalent to a product already on the market, but it is not itself approved by the FDA as a safe product.) As part of their impetus for introducing the bill, its authors cited to concerns raised by the Government Accountability Office (GAO) when it placed the FDA on its “high risk list” (see www.gao.gov/highrisk/risks/safety-security/public_health.php), as well as to the case of the DePuy hip implant, which was recalled only after the FDA and the manufacturer learned through foreign registries that patients were experiencing problems with the device. If the bill becomes law, manufacturers failing to conduct required post-market monitoring of their product's safety could find their permission to sell rescinded.