WASHINGTON (AP) — 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.
The GAO previously faulted the FDA in a 2009 for not reclassifying more than 26 types of devices so they receive more stringent reviews. Since then, the agency has cleared 67 individual, high-risk devices through the so-called 510(k) system, which is used to clear the vast majority of devices.
Devices classified as high-risk tended to be ones that are implanted in the body or could spell the difference between life and death.
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