FDA Updates MDUFA V User Fees for FY 2025
by Audrey Skeen
Regulation: MDUFA V
Issuing Authority: Food and Drug Administration (FDA)
Effective Date: October 1, 2024 – September 30, 2025
Updated FY 2025 User Fees
The FDA has announced the updated FY 2025 (October 1, 2024, through September 30, 2025) User Fees. The notice in the Federal Register establishes the rates for FY 2025, and details how the fees were determined, the procedures for paying necessary application fees, and the requirements an organization must meet to qualify as a Small Business for the purposes of following the reduced small-business fee schedule.
For FY 2025, the FDA’s budget summary outlines an overall increase in user fees to support the ODE’s activities, including reviewing medical device submissions like 510(k), PMA, and De Novo applications. These fees are essential for the ODE to function effectively, as they fund the necessary resources for timely and thorough evaluations of medical devices.
The increase from 2024-2025 was 11.8%, with the exception of the Registration fee which increased by 21.3%.
At a glance —
- The FDA has announced the updated FY 2025.
- The increase from 2024-2025 was 11.8%, with the exception of the Registration fee which increased by 21.3%.
- The Establishment Registration Fee is increased starting October 1 of this year.
- There are no major changes to compliance requirements.
| Application Type | Standard Fee | Small Business Fee† |
| 510(k)‡ | $24,335 | $6,084 |
| 513(g) | $7,301 | $3,650 |
| PMA, PDP, PMR, BLA | $540,783 | $135,196 |
| De Novo Classification Request | $162,235 | $40,559 |
| Panel-track Supplement | $432,626 | $108,157 |
| 180-Day Supplement | $81,117 | $20,279 |
| Real-Time Supplement | $37,855 | $9,464 |
| BLA Efficacy Supplement | $540,783 | $135,196 |
| 30-Day Notice | $8,653 | $4,326 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $18,927 | $4,732 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.
‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Four Novel Solutions in Six Months
The Establishment Registration Fee is increased starting October 1 of this year. Similarly, submissions for FY 2025 (after October 1, 2024) will follow the updated fee schedule.
As stated in the announcement, you should pay the application fee at the time you submit your application to FDA to avoid delay in the review of your application. Also note that FDA must receive the correct fee at the time that an application is submitted, or the application will not be accepted for filing or review.
There are no major changes to compliance requirements. Please refer to the official notice in the Federal Register for additional information and procedures for paying application fees.
Small Business Fee Reductions and Waivers
If your business, including affiliates, has gross receipts or sales of no more than $100 million for the most recent tax year, you may qualify for reduced small business fees. Additionally, if gross sales or receipts are no more than $30 million, you may qualify for a waiver of the fee for your first premarket application or report. Submit materials showing qualification as a small business at least 60 days before sending your submission to FDA. See Section IX Small Business Fee Reductions and Fee Waivers for details.
Additional Resources
What is MDUFA?
Device user fees were first established by the Medical Device User Fee and Modernization Act in 2002 and renewed through Medical Device User Fee Amendments (MDUFA) to the FDA Amendments Act. MDUFA V will be in place until September 30, 2027. The user fee system requires the FDA to collect user fees from manufacturers to review medical devices before they go to market. The fees are intended to supplement congressional appropriations, and the budget for the FDA’s Office of Device Evaluation (ODE) primarily comes from these user fees.
These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
The FY 2025 fee adjustment is intended to help meet targets required for the FDA to continue its operations and improve its processes and infrastructure for medical device evaluations.
Medical Device User Fee Amendment FY 2025 Updates
Medical Device User Fee Rates for Fiscal Year 2025
MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
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