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% |
