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Device user fee legislation

This article was originally published in The Gray Sheet

Executive Summary

Sen. Edward Kennedy (D-Mass.) is readying legislation that would establish FDA user fees for device manufacturers. Under the bill, some collected funds would be applied to FDA's device programs and some funds would go to the federal Treasury for deficit reduction. Rep. Henry Waxman (D-Calif.) reportedly is drafting a similar measure. President Clinton's economic plan calls for device user fees as a deficit reduction tool ("The Gray Sheet" Feb. 22, p. 1). The Health Industry Manufacturer's Association says it remains opposed to any type of user fees and believes that the device center's resource problems should be addressed through Congressional appropriations.

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