FDA UPDATE

Medical Device User Fee Amendments (MDUFA) FY2026 –

!Exciting News for Small Businesses!

The FDA has officially released the Medical Device User Fees for FY2026, and there’s great news for small business firms! For the first time ever, the FDA is offering a waiver for the Annual Establishment Registration Fee—a huge win for qualifying small businesses!

Who qualifies for Medical Device User Fee Amendments?

Small Business Determination (SBD) Program may be eligible for this waiver if:

• The business and its affiliates have gross receipts and sales of $1 million or less
• They can demonstrate financial hardship (e.g., proof of bankruptcy)
• They have paid the registration fee in a previous year

✅ This waiver can significantly reduce the financial burden for early-stage or struggling firms—a major step forward in supporting medical innovation from small enterprises! Especially since the FDA user fee for the coming fiscal year is going up to $11,423.

📅 FY2026 Period: October 1, 2025 – September 30, 2026
💲 Annual Establishment Registration Fee: $11,423

As expected, all other MDUFA application fees have increased by approximately 7% compared to FY2025. Here’s a quick look at the updated fees:

Application Type	Standard Fee FY2025	Small Business Fee FY2025	Standard Fee FY2026	Small Business Fee FY2026
510(k)‡	$24,335	$6,084	$26,067	$6,517
513(g)	$7,301	$3,650	$7,820	$3,910
PMA, PDP, PMR, BLA	$540,783	$135,196	$579,272	$144,818
De Novo Classification Request	$162,235	$40,559	$173,782	$43,446
Panel-track Supplement	$432,626	$108,157	$463,418	$115,855
180-Day Supplement	$81,117	$20,279	$86,891	$21,723
Real-Time Supplement	$37,855	$9,464	$40,549	$10,137
BLA Efficacy Supplement	$540,783	$135,196	$579,272	$144,818
30-Day Notice	$8,653	$4,326	$9,268	$4,634
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)	$18,927	$4,732	$20,275	$5,069

 

The FDA’s FY2026 user fee update isn’t just a regulatory change—it’s a strategic opportunity. With the introduction of the first-ever Annual Establishment Registration Fee waiver for eligible small businesses, now is the time to evaluate your company’s status and leverage this cost-saving benefit.

By partnering with mdi Consultants, you can:

• Assess your eligibility under the Small Business Determination (SBD) Program
• Apply for fee reductions or waivers to maximize savings
• Plan smarter submissions to avoid unnecessary delays and expenses
• Stay compliant while keeping your focus on innovation and growth

Let us help you use this policy shift to reduce costs, optimize your regulatory path, and stay competitive in the medical device market.

If you have any questions on FDA fees do not hesitate to contact mdi.

For more information on User Fees, please email us at:

info@mdiconsultants.com and ref: User Fees.