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DEVICE USER FEE PASSAGE THIS SESSION IN DOUBT

This article was originally published in The Gray Sheet

Executive Summary

DEVICE USER FEE PASSAGE THIS SESSION IN DOUBT as Congress nears the end of the legislative session. Factors working against passage of the Medical Device User Fee Act (HR 4864/S 2276), staffers say, include Congress' full agenda, members' desire to return to their districts and campaign for re-election, and a partisan debate on health care reform that is affecting negotiations on other legislation. The device user fee bill, which was introduced in the House and Senate on July 12 ("The Gray Sheet" July 18, p. 1), would impose fees on premarket applications for medical devices; the funds would be applied toward review functions within FDA's Center for Devices and Radiological Health. On the House side, the Energy and Commerce Committee approved the bill on Aug. 9 by a vote of 31 to 13 ("The Gray Sheet" Aug. 15, p. 1). The Senate has yet to take any action on the measure.
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