Regulatory Focus™ > News Articles > GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

Posted 29 March 2012 | By Alexander Gaffney, RAC 

The US Government Accountability Office (GAO) released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device reviews, but that overall medical device review time was trending upward.

The discrepancy comes down to a difference in how FDA's performance is evaluated relative to the total time it takes to review a medical device under the 510(k) evaluation pathway.

Under so-called "FDA time," the agency stops the review clock every time it requests that a sponsor submit additional information necessary to complete the application. This time lost does not count toward FDA's Medical Device User Fee Act III (MDUFA) performance goals, but does serve to increase the amount of time spent per application.

"Although FDA review time decreased slightly from FY 2003 through FY 2010, the time that elapsed before FDA's final decision increased substantially," wrote GAO in its report.

Premarket applications (PMAs) were not reviewed nearly as consistently, according to GAO's analysis. FDA failed to review PMA submissions to agreed-upon performance goals in three of the seven years since 2005 and only twice in seven years for expedited PMAs.

"FDA review time and time to final decision for both types of PMAs were highly variable but generally increased in recent years," wrote GAO. "For example, the average time to final decision for original PMAs increased from 462 days for FY 2003 to 627 days for FY 2008 (the most recent year for which complete data are available)."

Read more:

GAO - FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer

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