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Medical Devices / Regulatory Affairs

FDA Center Directors Urge Lawmakers to Advance User Fees

March 29, 2017

Three senior FDA officials urged a Senate HELP Committee hearing last week to move forward on user fees for devices or risk funding problems at the agency.

CDRH Director Jeffrey Shuren, CDER Director Janet Woodcock, and CBER Director Peter Marks highlighted the achievements of the current generation of user fee programs — such as clearing the backlog of device premarket approval applications and 510(k)s — and said the agency depends on user fees to fund essential programs.

Committee Chair Lamar Alexander (R-Tenn.) said if Congress does not reauthorize the FDA’s user fees before July 27, the agency would be forced to begin notifying more than 5,000 employees that they could lose their jobs come October, when the user fee programs expire.

The center directors unexpectedly found themselves in the middle of a partisan debate over repeal of the Affordable Care Act, with the committee’s Democrats arguing the time spent on user fees would be better spent debating the Republican bill scheduled for a House vote.

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