GAO report: FDA failed to thoroughly evaluate high-risk devices

01/15/2009 | Washington Post, The

The FDA cleared 228 high-risk medical devices from 2003 to 2007 without placing them under comprehensive scientific review, according to a report from the Government Accountability Office. The GAO also found that the FDA continues to approve newer forms of such products if they are deemed "substantially equivalent" to their precursors despite an order from Congress to discontinue the practice. The FDA agrees with the report's findings and suggestions, and is exploring options to address the issue, an agency spokeswoman said.

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