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FDA review performance update

This article was originally published in The Gray Sheet

Executive Summary

FDA's device center remains on track to meet its pre-market review performance goals for fiscal year 2008 (ended Sept. 30), according to the latest quarterly industry update. In FY 2008, CDRH received 31 pre-market applications and panel-track supplements, 25 of which await an FDA decision. The agency is meeting its goal of completing decisions on 60% of applications within 180 days of filing and 90% of them within 295 days. FDA received 248 180-day supplements, of which 36 await an FDA decision; 169 real-time PMA supplements, of which 104 await a decision; and 3,851 510(k) submissions, with 1,467 (or 40%) awaiting a decision. CDRH collected the expected $48.4 million in registration and application/reporting fees in FY 2008, compared with $26.9 million in FY 2007. Fiscal 2008 was the first year FDA began collecting establishment registration fees
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