The FDA today set the user fee rates for fiscal 2020, which is slated to begin in October, raising all but one of the fees across the board by nearly 6%.
Medical device makers pay user fees to have the FDA review their products. The rates rose by nearly 4% for fiscal 2019.
The agency gave filers for premarket approval (PMA), product development protocol (PDP), premarket report (PMR) and biologics license application (BLA) a break, raising those fees by 2.7% for FY 2020. The fees for small businesses making less than $100 million annually, and for their larger brethren, are paid to the FDA’s Center for Devices & Radiological Health.
The agency hiked fees by more than 33%, with the fee for one popular protocol jumping more than 125%, for fiscal 2018.
Here’s how this year’s changes break down:
Application type | Fee for FY20 | Fee for FY19 | % change | Small business fee FY20 | Small business fee FY19 | % change |
510(k) premarket notification submission | $11,594 | $10,953 | 5.9% | $2,899 | $2,738 | 5.9% |
513(g) request for classification information | $4,603 | $4,349 | 5.8% | $2,302 | $2,175 | 5.8% |
PMA, PDP, PMR, BLA | $340,995 | $332,147 | 2.7% | $85,249 | $80,537 | 5.9% |
Panel-track supplement | $255,747 | $241,610 | 5.9% | $63,937 | $60,403 | 5.9% |
180-day supplement | $51,149 | $48,322 | 5.9% | $12,787 | $12,081 | 5.8% |
Real-time supplement | $23,870 | $22,550 | 5.9% | $5,968 | $5,638 | 5.9% |
Annual fee for periodic Class III reporting | $11,935 | $11,275 | 5.9% | $2,984 | $2,819 | 5.9% |
30-day notice | $5,456 | $5,154 | 5.9% | $2,728 | $2,577 | 5.9% |