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."