High risk medical devices escaped close review
AP/Yahoo News, January 16, 2009
Some medical devices for sensitive uses 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 2003-2007, the Government Accountability Office said in a report. Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen.