GAO Criticizes FDA For Lax Medical Device Oversight

The Government Accountability Office has criticized the FDA for its lax oversight of medical devices, particularly artificial hips. The Senate Special Committee on Aging will hear testimony from industry experts and safety advocates concerning the FDA’s regulatory process in approving such medical devices today. Testimony will include an examination of the now recalled DePuy ASR XL hip which was approved for use without rigorous clinical trials because of a regulatory loophole. The Senate hearing will also examine why DePuy Orthopedics continued to market and sell the DePuy ASR XL after doctors complained about unacceptably high failure rates.
According to the NY Times, “The F.D.A. has two separate procedures for approving medical devices.
For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market. For devices that are more critical, like implanted heart defibrillators, producers have to run clinical trials to win approval.
But some categories of high-risk products like artificial hips and external defibrillators that were already on the market when the F.D.A. began to regulate devices can still enter the market through the less-rigorous pathway. Safety advocates have long urged the F.D.A. to close that loophole.”