Like Everything Else, Medical Device User Fees Are Not Immune to Price Increases
October 21, 2022If you have purchased anything in recent months or kept up with economic reports, you are familiar with the unwelcome observation: “Prices have gone up!” That could not be more true than in the area of medical device user fees.
Medical Device User Fees
After the Congressional passage of Medical Device User Fee Amendments of 2022 (MDUFA V), which was signed into law by President Biden, FDA posted medical device user fees for Fiscal Year 2023 (i.e., October 1, 2022 through September 30, 2023). See here for the medical device user fees for FY2023. We produced a table below using the medical device user fee information for FY2022 and for FY2023 to show year over year changes.
| Standard Fee | Small Business Fee | |||||||
| Application Type | FY2022 | FY2023 | Dollar Change | Percent Change | FY2022 | FY2023 | Dollar Change | Small Business Fee |
| 510(k) | $12,745 | $19,870 | $7,125 | 56% | $3,186 | $4,967 | $1,781 | 56% |
| 513(g) | $5,061 | $5,961 | $900 | 18% | $2,530 | $2,980 | $450 | 18% |
| PMA, PDP, PMR, BLA | $374,858 | $441,547 | $66,689 | 18% | $93,714 | $110,387 | $16,673 | 18% |
| De Novo Classification Request | $112,457 | $132,464 | $20,007 | 18% | $28,114 | $33,116 | $5,002 | 18% |
| Panel-track Supplement | $281,143 | $353,238 | $72,095 | 26% | $70,286 | $88,309 | $18,023 | 26% |
| 180-Day Supplement | $56,229 | $66,232 | $10,003 | 18% | $14,057 | $16,558 | $2,501 | 18% |
| Real-Time Supplement | $26,240 | $30,908 | $4,668 | 18% | $6,560 | $7,727 | $1,167 | 18% |
| BLA Efficacy Supplement | $374,858 | $441,547 | $66,689 | 18% | $93,714 | $110,387 | $16,673 | 18% |
| 30-Day Notice | $5,998 | $7,065 | $1,067 | 18% | $2,999 | $3,532 | $533 | 18% |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $13,120 | $15,454 | $2,334 | 18% | $3,280 | $3,864 | $584 | 18% |
As you can see, the percent changes for medical device user fees from FY2022 to FY2023 ranged from 18% to a whopping 56%!
The eye-catching 56% increase for a 510(k) submission could be burdensome to many device manufacturers given that the 510(k) premarket notification is the most frequently used regulatory pathway for medical devices. In terms of the percent change, the increase in medical device user fees from FY2022 to FY2023 is much higher than the increases in previous years (7% increase from FY2020 to FY2021; 3% increase from FY2021 to FY2022; these percentages were across the board and did not vary according to submission type). The same is true when the range of the percent change in the medical device user fees from FY2022 to FY2023 is compared to other FDA programs (e.g., prescription drug user fees, generic drug user fees, and biosimilar user fees).
Suggestion for Industry
Given the substantial increase in the medical device user fees for FY2023 and the likelihood of further increases in FY 2024 − FY 2026, device manufacturers should take advantage of reduced fees if they qualify as a small business. In our next blog post, we will provide practical guidance on applying as such through FDA’s Small Business Determination Program.