Failed oversight

March 2009
CMAJ: Canadian Medical Association Journal;3/31/2009, Vol. 180 Issue 7, p709
Academic Journal
The article reports on the study conducted by the U.S. Government Accountability Office (GAO) on the U.S. Food and Drug Administration's (FDA) process for approving high-risk class III medical devices. The report states that the FDA's process is outdated, and fails to ensure the safety and effectiveness of such products. Moreover, the report shows that FDA allowed 24 different types of class III devices to be cleared though they were that class I and class II devices.


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