Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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.



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts