The FDA has published its Medical Device User Fees for FY 2025 (here) and the reason there are no surprises is that the fees all went up. The new fees are effective on October 1, 2024. The Federal Register Notice (FR) “provides information on how the fees for FY 2025 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.”
The new fees are based on inflation adjustment factors, staffing needs, salary increases, and estimates of workload, which is a three-year look back at actual submission numbers for FY 2021 through FY 2023. Of course, these estimates are the best-guess scenario for the actual number of submissions. As we have seen for the GDUFA model, the projection is actually a decrease in submissions for ANDAs, but for medical devices, at least now, we do not see any trends that suggest a decrease in submissions.
Comparison of FY 2024 and FY 2025 Medical Device User Fees
