TITLE

Failed oversight

PUB. DATE
March 2009
SOURCE
CMAJ: Canadian Medical Association Journal;3/31/2009, Vol. 180 Issue 7, p709
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
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 The report states that the FDA's process is outdated, and fails to ensure the safety and effectiveness of such products.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.
ACCESSION #
37371371

 

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