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FDA raises medical device user fees more than 4%

By Brad Perriello

The FDA is raising the user fees medical device makers pay for the safety watchdog to review its products by more than 4%.

The user fees for fiscal 2016, which begins Oct. 1, 2015 are going up 4.2% over the fiscal 2015 fees for both small businesses making less that $100 million annually and for their larger brethren, the FDA’s Center for Devices & Radiological Health said today.

The cuts are slated to cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA. The agency cut the fees by -2.9%for fiscal 2015, having raised them by 4.2% for FY2014.

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