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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Source: Mass Device - July 30, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance User fees Source Type: news