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Tentative agreement reached on medical device user fees

Feb 02, 2012 03:51 PM

After months of negotiations and hearings, the Food and Drug Administration (FDA) and the medical device industry have reached what they call an agreement in "principle" on recommendations to the medical device user fee program.

Under the terms of the new agreement, the industry will pay $595 million in user fees over the next five years, plus adjustments for inflation, to help fund a portion of the agency's device review activities.

FDA Commissioner Margaret A. Hamburg said the agreement will help improve the pre-submissions process, as well as boost innovation in order to spur development and create more medical device jobs.

"I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees," Commissioner Hamburg noted. "Reauthorization of this important program is an essential component for advancing medical device innovation."

Once a final agreement is reached, the proposal will be sent to Congress for approval.

The FDA was under the gun to submit the terms of the agreement to lawmakers by February 15, after missing an earlier filing deadline. The agency originally wanted to collect as much as $805 million in fees.

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