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Device groups agree on user-fee remedy?

This article was originally published in The Gray Sheet

Executive Summary

AdvaMed will consider seeking legislative action to stem the rate of user fee increases, the association says, following FDA's formal announcement of a 15.7% jump in PMA fees for FY 2005. The notice will be published in the Aug. 2 1Federal Register. Coupled with the 35% rise in FY 2004 user fees, "the 2005 increase...set[s] a pace that cannot be maintained," AdvaMed contends July 30. The Medical Device Manufacturers Association, a longstanding critic of MDUFMA's fee-increase structure, intensified its push for legislative changes soon after the 2004 fees were unveiled. Enacted rates, based on a full-fee PMA charge of $239,237, will be identical to those proposed at the July 15 quarterly MDUFMA meeting (2"The Gray Sheet" July 19, 2004, p. 3)...

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