GAO: FDA Device Approval Process Endangers Patients

The AP reported, "Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters."  The "Government Accountability Office told Congress Wednesday that the approvals remain a serious issue for the government -- more than two years after the watchdog agency first cited the problem to the FDA." In response, Dr. William Maisel, deputy director for science in FDA's device center, said that the agency "will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012."


CQ reported that the GAO findings were based on an "analysis of 3,510 voluntary recalls from 2005 through 2009." The results were "discussed as part of a debate over whether the agency should update the so-called 510(k) process, which is the main procedure for approving medical devices. The process was intended to be an approval route for products similar to those already on the market; unlike another rarely-used and more stringent review for new products, known as the premarket approval (PMA) process, the 510(k) procedure does not require manufacturers to test devices in people before selling them in the United States."