Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Device review times continue to slip: FDA does not yet know whether it will meet its fiscal 2009 goals for the amount of time it takes to issue decisions on pre-market approval applications, certain PMA supplements, and 510(k) submissions, according to recently posted device review data from an April 20 performance report. Agency reviewers missed certain performance goals for expedited PMAs and PMA modules, and may miss review goals for PMAs and 510(k)s, though it is too soon to say. FDA did not meet its fiscal 2008 goals for PMAs, expedited PMAs or modular PMAs, either, but achieved goals for issuing decisions on 180-day PMA supplements, real-time PMA supplements and 510(k)s (1"The Gray Sheet" April 26, 2010). CDRH Director Jeffrey Shuren attributes the lagging review times to an increasingly complex workload (2"The Gray Sheet" May 10, 2010). The performance goals were established under device user fee legislation enacted in 2007