FDA's User Fees for Medical Devices slated for 2024
The Food and Drug Administration (FDA) has revealed the fees and payment procedures for medical device user fees for the fiscal year 2024. Small businesses with approved Small Business Determination (SBD) and gross receipts or sales of $100 million or less may be eligible for reduced fees for various types of submissions.
For small businesses, the user fee for a Premarket Notification (510(k)) in FY 2025 is $6,084, a reduction compared to the standard fee. The Annual Establishment Registration fee for medical device facilities in FY 2025 is $9,280.
While the exact FY 2023 and FY 2024 fees for small businesses are not directly provided, small businesses are advised to review the FDA's official MDUFA fee schedules for each fiscal year, compare the annual establishment registration and 510(k) premarket notification fees specifically, and check for any FDA Federal Register Notices (FRNs) released around mid-year to confirm the new fees for FY 2024.
The FDA has published a table summarising the differences in medical device user fees for 2024 compared to 2023. The table, available in the Federal Register for Fiscal Year 2024 medical device user fees, provides a comparison of fees for various types of submissions, such as Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), and Biologics License Application (BLA).
All establishments must pay an FDA annual registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2024. The table does not indicate the deadline for paying the new 2024 fees or the date when the old 2023 fees will no longer be accepted.
The fees assist the FDA in improving the effectiveness of regulatory procedures to speed up the process of bringing safe and effective medical devices to the U.S. market. The table does not specify how the fees are used to support these improvements.
Small businesses are encouraged to consult the FDA’s official MDUFA fee announcements and guidance documents for precise year-to-year fee comparisons and to confirm their eligibility for small business fee reductions. This approach ensures firms accurately budget for registration and approval costs on an annual basis.
- Small businesses can find the reduction in user fees for Premarket Notification (510(k)) in the fiscal year 2025, as stated in the FDA's published table.
- The fees for various types of submissions such as Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), and Biologics License Application (BLA), are compared in the table for medical device user fees in FY 2024.
- While the FDA has not directly provided the exact fees for small businesses for FY 2023 and FY 2024, the agency advises reviewing the official MDUFA fee schedules for each fiscal year to confirm the new fees for FY 2024.
- All businesses, regardless of size, are required to pay an FDA annual registration fee, but only small businesses with approved Small Business Determination may be eligible for reduced fees for various types of submissions. The table for FY 2024 does not specify the deadline for paying the new 2024 fees or the date when the old 2023 fees will no longer be accepted.
