Congressional investigators reported that the Food and Drug Administration approved 228 medical devices without a full scale review from 2003-2007. These devices, ranging from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, causing concern over possible future recalls or problems.
The investigation by the Government Accountability Office “confirms my concerns that the approval process for medical devices is woefully inadequate," said Rep. Frank Pallone, who heads the House Energy and Commerce Committee's health panel. "For years, Congress has required high-risk medical devices to undergo stringent premarket review, but GAO's findings show that is simply not happening in every case." Pallone said he intends to hold hearings on the FDA's oversight of medical devices. The GAO did not look into whether any patients were harmed as a result of devices that got less government scrutiny.
The report urged the FDA to promptly resolve the problem, either by carrying out full reviews or reclassifying some devices as lower risk, if appropriate. The FDA acknowledged the problem, but has not set a timetable for resolving it. "It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk," said Peter Lurie, deputy director of Public Citizen's health research group.