Medical Device User Fee Amendments (MDUFA)
User Fees for FY 2025
Annual Establishment Registration Fee: $9,280
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025.
Other fees for Fiscal Year 2025 (October 1, 2024, through September 30, 2025) are:
| 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. For more information, see the section Small Businesses below.
‡ 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.
Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in:
- 2007, with the Medical Device User Fee Amendments (MDUFA II) to the FDA Amendments Act (FDAAA)
- 2012, with the Medical Device User Fee Amendments (MDUFA III) to the FDA Safety and Innovation Act (FDASIA)
- 2017, with the Medical Device User Fee Amendments (MDUFA IV) to the FDA Reauthorization Act (FDARA).
- 2022, with the Medical Device User Fee Amendments (MDUFA V) to the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023. MDUFA V will be in place from October 1, 2022 until September 30, 2027.
Under the user fee system, medical device companies pay fees to the FDA when they submit a premarket submission to market a new medical device in the U.S., and when they register their establishments and list their devices with the agency. 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.
Waivers: Small businesses certified through the Small Business Determination (SBD) program with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), or Biologics License Application (BLA).
Reduced Fees: Small businesses certified through the Small Business Determination (SBD) program with gross receipts or sales of $100 million or less are eligible for a reduced fee on: Premarket Notification (510(k)), De Novo request, Premarket Applications (Premarket Approval Application (PMA), Biologics License Application (BLA), Product Development Protocol (PDP), Premarket Report (PMR), PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification information.
Submitting a Small Business Determination (SBD) Request: CDRH's SBD Program determines whether a business is qualified and certified as a "small business" and eligible for a reduced fee for some types of CDRH submissions that require a user fee. For details on submitting a SBD request, see Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
- FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
- User Fees and Refunds for De Novo Classification Requests
- User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
- User Fees and Refunds for Premarket Notification Submissions (510(k)s)
- User Fees and Refunds for 513(g) Requests for Information
- Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
For other guidance documents, see MDUFA Guidance Documents.