FDA Word on User Fees
AdvaMed Responds to FDA Word on User Fees
ADVAMED EXPRESSED dissatisfaction with the FDA's July 30 2004 announcement that user fees for most medical technology applications will rise nearly 16 percent in FY 2005. The new user fee rates appeared in the August 2 edition of the Federal Register. FDA has agreed, however, to seek an independent cost analysis of its application review processes.
This audit - originally proposed by AdvaMed - will help Congress and other stakeholders better understand future resource requirements for reviewing new product applications.
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