Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said.
Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full-scale review from 2003-07, the Government Accountability Office said in a report.
"GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate," said Rep. Frank Pallone Jr. (D-N.J.), 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."
The FDA acknowledged the problem, but has not set a timetable for resolving it. "In general, we agree with the conclusions and recommendations," said spokeswoman Karen Riley. "We are considering legal and procedural options to accomplish this objective."
The GAO report found that two-dozen distinct types of devices were approved without close scrutiny, including metal hip joints, external defibrillators and electrodes for pacemakers.