GAO Renews Critique of FDA Medical Device System
WASHINGTON (AP) — Government investigators say the FDA is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same speedy system intended for power wheelchairs, stitches and catheters.
The Government Accountability Office will tell 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, according to testimony obtained by the Associated Press.
The GAO previously faulted the FDA in 2009 for not reclassifying more than two dozen types of devices so they receive more stringent review.
Wednesday's hearing on the FDA's oversight of devices comes as the agency faces criticism from medical device manufacturers, who say reviews have become too slow and burdensome.