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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Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat User fees Source Type: news