dilluns, 30 de juliol del 2018

FDA user fees set to rise 4% in fiscal 2019

FDAThe 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%

The post FDA user fees set to rise 4% in fiscal 2019 appeared first on MassDevice.



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