Medical device industry agrees to FDA's device user fees to raise regulatory funding

The Food and Drug Administration reached an agreement with representatives of the medical device industry for proposed recommendations of the medical device user fee program.

Through the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees starting October 17, including adjustments for inflation over the next five years. The money would be used to fund the agency's medical device review program.

"This draft agreement represents a substantial investment in the future of the agency's medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health.

The draft agreement will be open for public comment within the next few weeks. The FDA will send its final recommendations to Congress in January 2017.

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