FDA user fees set to rise 4% in fiscal 2019

The FDA last week set the user fee rates for fiscal 2019, which is slated to begin in October, raising the fees across the board by nearly 4%.

Medical device makers pay user fees to have the FDA review their products. The rates jumped by more than 33%, with the fee for one popular protocol jumping more than 125%, for fiscal 2018.

The fees for small businesses making less that $100 million annually, and for their larger brethren, are paid to the FDA’s Center for Devices & Radiological Health.

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 FY19	Fee for FY18	% change	Small business fee FY19	Small business fee FY18	% change
510(k) premarket notification submission	$10,953	$10,566	3.7%	$2,738	$2,642	3.6%
513(g) request for classification information	$4,349	$3,166	3.7%	$2,175	$2,098	3.7%
PMA, PDP, PMR, BLA	$322,147	$310,764	3.7%	$80,537	$77,691	3.7%
Panel-track supplement	$241,610	$233,073	3.7%	$60,403	$58,268	3.7%
180-day supplement	$48,322	$46,615	3.7%	$12,081	$11,654	3.7%
Real-time supplement	$22,550	$21,753	3.7%	$5,638	$5,438	3.7%
Annual fee for periodic Class III reporting	$11,275	$10,877	3.7%	$2,819	$2,719	3.7%
30-day notice	$5,154	$4,972	3.7%	$2,577	$2,486	3.7%

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