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www.fdanews.com/articles/182016-device-user-fees-would-skyrocket-under-proposed-trump-budget

Device User Fees Would Skyrocket Under Proposed Trump Budget

June 2, 2017

In a change that would more than triple fees paid by devicemakers, the Trump administration’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission.

Under the proposal, funds collected under MDUFA would increase from the $126 million anticipated for fiscal 2017 to an expected $439 million for fiscal 2018.

The proposal would cut the agency’s overall federal funding by $854 million and replace it with $866 million in industry user fees, which would mean an overall increase of 78.6 percent in funding from industry.

“In a constrained budget environment, the budget acknowledges medical product industries have sufficiently matured to assume a greater share of costs associated with FDA’s administrative actions,” the budget justification document says.

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