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High-Risk Medical Devices Fail to Get Full Review, GAO Says

High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found.

The Food and Drug Administration gave expedited reviews to at least 67 devices such as pacemakers and hip joints since the GAO called in January 2009 for “immediate steps” to increase standards or reclassify potential risks, Marcia Crosse, GAO’s director of health care, told lawmakers in Washington today. While the FDA has enhanced its oversight, she said, it continues to review 26 of 27 types of high-risk devices cited in 2009.