FDA, New Medical Device User Fees for FY 2026
- Provision Consulting Group
- Aug 1
- 2 min read
On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30, 2026). These fees are mandatory for companies involved in device registration, regulatory submissions, and certain post-market reporting activities.
What Are FDA Medical Device User Fees?
To register a medical device with the FDA or obtain market authorization—such as through a 510(k), De Novo, or PMA submission—manufacturers and importers are required to pay Medical Device User Fees.
These fees serve as a financial foundation for FDA’s review programs, helping the agency maintain timely review performance. The Medical Device User Fee Amendments (MDUFA) program was first established in 2002 and has since been updated and adjusted annually.
Annual Establishment Registration Fee
Fee Amount: $11,423
Required for: All U.S. and foreign medical device manufacturers and importers
Small Business Reduction: Not available for the annual registration fee
※ However, except for initial registration, companies certified under the FDA’s Small Business Program and demonstrating financial hardship may be eligible for partial relief.
Application Fees
Application Type | Standard Fee | Small Business Fee |
510(k) Submission | $26,067 | $6,517 |
513(g) Request | $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 Class III Device Periodic Reporting | $20,275 | $5,069 |
† 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.
For more information, please refer to the following link.
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