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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Device reviewers miss some performance goals: FDA did not meet its fiscal 2008 goals for issuing decisions on certain device pre-market submissions, according to materials from FDA's latest quarterly update to industry. Federal law requires FDA to endeavor to reach a decision on 60% of pre-market approval submissions and panel-track PMA supplements within 180 days, and on 90% of PMAs and panel-track supplements within 295 days. In FY 2008, CDRH made decisions on 23 of 33 PMAs and panel-track supplement submissions. Some decisions are still pending, but in the best-case scenario, the center will miss its 295-day performance goal, and may miss its 180-day goal, as well. CDRH also missed its performance goals for expedited PMAs and expedited panel-track supplements (50% of decisions within 180 days and 90% of decisions within 280 days). The center similarly missed its performance goals for PMA modules, but will meet its performance goal for 180-day supplements and real-time supplements. CDRH also met its goal for 510(k) decisions, reaching decisions on more than 90% of submissions within 90 days and more than 98% of submissions within 150 days. CDRH received 3,848 510(k)s in FY 2008 and 4,103 510(k)s in FY 2009. And signals indicate that reviews may be speeding up. Average time to a final decision on PMAs and panel-track supplements was 215 days in FY 2008 and 172 days in FY 2009. 510(k) decisions took about 112 days on average in FY 2008 and 88 days in FY 2009, FDA says

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Regulatory News In Brief

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

Regulatory News In Brief

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

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