Medical Device User Fee Amendments (MDUFA): Fees
User Fees for FY 2026
October 1, 2025, through September 30, 2026.
Annual Establishment Registration Fee: $11,423
Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee. For payment timing, see When to Register and List.
For FY 2026, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses qualified through the Small Business Determination (SBD) Program who demonstrate that paying the fee represents financial hardship as determined by the FDA. For more information, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
Application Fees:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $26,067 | $6,517 |
| 513(g) | $7,820 | $3,910 |
| PMA, PDP, PMR, BLA | $579,272 | $144,818 |
| De Novo Classification Request | $173,782 | $43,446 |
| Panel-track Supplement | $463,418 | $115,855 |
| 180-Day Supplement | $86,891 | $21,723 |
| Real-Time Supplement | $40,549 | $10,137 |
| BLA Efficacy Supplement | $579,272 | $144,818 |
| 30-Day Notice | $9,268 | $4,634 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $20,275 | $5,069 |
† Small Business Fee: For businesses qualified by the Center for Devices and Radiological Health (CDRH) as a small business. For information about qualification, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
‡ 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.
User Fees for FY 2027
October 1, 2026, through September 30, 2027.
Annual Establishment Registration Fee: $13,785
Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee. For payment timing, see When to Register and List.
For FY 2027, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses qualified through the Small Business Determination (SBD) Program who demonstrate that paying the fee represents financial hardship as determined by the FDA. For more information, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
Application Fees:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $28,653 | $7,163 |
| 513(g) | $8,596 | $4,298 |
| PMA, PDP, PMR, BLA | $636,732 | $159,183 |
| De Novo Classification Request | $191,020 | $47,755 |
| Panel-track Supplement | $509,386 | $127,347 |
| 180-Day Supplement | $95,510 | $23,878 |
| Real-Time Supplement | $44,571 | $11,143 |
| BLA Efficacy Supplement | $636,732 | $159,183 |
| 30-Day Notice | $10,188 | $5,094 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $22,286 | $5,572 |
† Small Business Fee: For businesses qualified by the Center for Devices and Radiological Health (CDRH) as a small business. For information about qualification, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
‡ 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 FDA User Fee Reauthorization Act (FDAUFRA). MDUFA V will be in place from October 1, 2022 until September 30, 2027.
- And are slated to be reauthorized in 2027, with the Medical Device User Fee Amendments (MDUFA VI).
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.
For information about making a user fee payment for a medical device premarket application, visit the Medical Device User Fees webpage.
For information about making a user fee payment for a medical device establishment registration, visit the Device Registration and Listing and Payment Process webpages.
- 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 Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
For other guidance documents, see MDUFA Guidance Documents.