GAO: FDA "inconsistent" in meeting performance goals
March 30, 2012 by MassDevice staff
The FDA met most performance goals between 2003
and 2010, but was inconsistent in its review of pre-market approval
applications, especially those marked "expedited," according to a
Government Accountability Office report.

The FDA lacks consistency in review times for medical device
pre-market approval applications, missing most goals for submissions
marked "expedited," according to report by the Government Accountability
Office.
"For FYs 2003 through 2010, FDA met most of the goals for original
PMAs but fell short on most of the goals for expedited PMAs," according
to the GAO report. "In addition, FDA review time and time to final
decision for both types of PMAs generally increased during this period."
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