FDA MDUFA 2026: Fees & Relief Update

Effective October 1, 2025, the FDA has increased the annual establishment registration fee by 23% under the Medical Device User Fee Amendments (MDUFA V).

FDA MDUFA Fee Reductions & Waivers

Through the Small Business Determination (SBD) Program, eligible U.S. and foreign businesses may benefit from:

1. Reduced Application Fees

• Available to businesses with ≤ $100 million in gross receipts or sales (combined with affiliates).
• Eligible application types include PMA, PDP, PMA and PDP Supplements (Panel-Track, 180-day, Real-Time and 30-day Notice), Modular PMA, BLA, BLA Efficacy Supplement, 510(k) (Traditional, Abbreviated, and Special), PMR, PMA Annual Reports, 513(g), and De Novo request.

2. First Premarket Application/Report Fee Waiver

• One-time fee waiver for businesses with ≤ $30 million in gross receipts and no previous qualifying submissions.
• Eligible application types include PMA, including Modular PMA, BLA, PDP, or PMR.

3. Establishment Registration Fee Waiver (NEW in FY 2026)

• Applies only to businesses with ≤ $1 million in gross receipts (including affiliates).
• Requires proof of prior paid registration.
• Must demonstrate financial hardship (e.g., active bankruptcy).
• Available starting FY 2026 only.

How to Qualify

To benefit from any of these FDA MDUFA reductions or waivers, businesses must:

• Apply annually via the FDA’s CDRH Portal
• Submit a Small Business Request (SBR) at least 60 days before the applicable fee is due
• Include:
  • Signed U.S. federal income tax returns (or equivalent national certification for foreign businesses)
  • Certification of gross receipts/sales, including all affiliates
  • Organization ID Number (Org ID)

For more information, click here:

• Medical Device User Fee Small Business Qualification and Determination | FDA
• Device Registration and Listing | FDA

How MedEnvoy Can Help

If you have any questions about this FDA MDUFA update or need help navigating the FDA Small Business Determination process, please feel free to reach out to us here. To learn more about our US FDA Agent Service, click here.