Most FDA user fees set to rise 33%

The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising by more than 33%, with the fee for one popular protocol jumping more than 125%.

All but one of the user fees for fiscal 2018, which begins Oct. 1, are going up 32.5% compared with the fiscal 2017 fees for both small businesses making less that $100 million annually and for their larger brethren, according to the FDA’s Center for Devices & Radiological Health.

But the fee for 510(k) clearance, the safety watchdog’s most common form of medical device review, jumped 125.3% to $10,566.

The agency cut the fees by -2.9% for fiscal 2015, having raised them by 4.2% for FY2014.

Here’s how this year’s changes break down:

Application type	Fee for FY18	Fee for FY17	% change	Small business fee FY18	Small business fee FY17	% change
510(k) premarket notification submission	$10,566	$4,690	125.3%	$2,642	$2,345	32.5%
513(g) request for classification information	$4,195	$3,166	32.5%	$2,098	$1,583	32.5%
PMA, PDP, PMR, BLA	$310,764	$234,495	32.5%	$77,691	$58,624	32.5%
Panel-track supplement	$233,073	$175,871	32.5%	$58,268	$43,968	32.5%
180-day supplement	$46,615	$35,174	32.5%	$11,654	$8,794	32.5%
Real-time supplement	$21,753	$16,415	32.5%	$5,438	$4,104	32.5%
Annual fee for periodic Class III reporting	$10,877	$8,207	32.5%	$2,719	$2,052	32.5%
30-day notice	$4,972	$3,752	32.5%	$2,486	$1,876	32.5%

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