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MDUFMA Stakeholder Meeting In Brief

This article was originally published in The Gray Sheet

Executive Summary

User fee-exempt submissions on the rise: Apparent drop in PMA, BLA and panel-track supplement workload from fiscal 2003 to 2004 is attributed to an increase in user fee-exempt applications. In FY 2004, CDRH logged 19 exempt applications, compared with 16 in 2003. The agency also received one exempt pediatric application (compared with none in 2003) and four bundled applications, up from the two bundled submissions the prior year. The workload has been largely stable, FDA budget staffer Frank Claunts observed during the Nov. 18 MDUFMA stakeholder meeting in Gaithersburg, Md. He cited a total of 69 applications in 2003, compared with 68.5 in 2004. Initially, FDA underestimated the number of applications that would qualify as totally exempt from user fees, budgeting for 10 first-time premarket submissions from small businesses, but receiving 16. Non-fee-paying 510(k)s also were up, climbing from 270 in 2003 to 385 in 2004. Last year, FDA overestimated the number of 510(k)s that would qualify for small business discounts, projecting an 80% qualification rate, when only 15% were granted the discount. The miscalculation helped keep the 510(k) fee rate increase from FY 2004 to FY 2005 essentially flat...

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