Medical Device User Fees

On July 31st, the U.S. Food and Drug Administration (FDA) released an updated final guidance, titled “Medical Device User Fee Small Business Qualification and Determination,” detailing the process for small businesses to qualify for reduced medical device user fees and waivers under the Medical Device User Fee Amendments (MDUFA). This revision supersedes the 2018 version and includes key updates for U.S. and foreign medical device companies seeking cost-saving opportunities in FY2026. With submission windows now open for FY 2026, the agency encourages qualified businesses to plan their request strategy accordingly.

Unpacking the Updated FDA Guidance 

This guidance outlines eligibility requirements for the FDA Center for Devices and Radiological Health’s Small Business Determination (SBD) Program, highlighting the benefits available to qualifying businesses, how to submit Small Business Requests (SBR), and the agency’s current documentation expectations. 

Medical device manufacturers must typically pay FDA fees for submissions such as 510(k)s, De Novos, PMAs, and annual establishment registrations. However, businesses that meet specific revenue thresholds can qualify for:

• Reduced Application Fees
• First Premarket Application or Report Fee Waiver
• Establishment Registration Fee Waiver (under financial hardship)

*NOTE: Each benefit has a different eligibility threshold and must be requested annually.

Eligibility Thresholds for FY 2026 

To qualify for SBD status, a company must demonstrate gross receipts or sales that fall below the following thresholds (including all affiliates):

• $100M or less: Reduced fees for 510(k)s, PMAs, De Novos, etc.
• $30M or less: Waiver for the first premarket application/report (PMA, BLA, PDP, or PMR)
• $1M or less: Waiver of the annual establishment registration fee based on financial hardship

Demonstration of Financial Hardship:

Outlined in Section Ⅳ. Guidance for U.S. Businesses of the final guidance, states that a business wishing to receive a registration fee waver must prove that the establishment is experiencing financial hardship in such year. The agency notes that the only instance they have granted a fee waiver for thus far, is for establishments who have filed for bankruptcy, which demonstrates financial hardship through public records. Within Section Ⅳ of the final guidance, the FDA lists recommends establishments wishing to apply for a registration fee waiver to provide all of the following documentation:

• "Your most recent Federal tax return(s) showing $1,000,000 or less in gross receipts or sales (including affiliates),"
• "Proof that you have filed a petition for bankruptcy in United States Bankruptcy Court and that the bankruptcy is currently active (debts have yet to be discharged or a reorganization plan has not been confirmed), and"
• "Evidence that the establishments for which you are seeking a waiver have, under your owner/operator ID with FDA, previously registered and paid the associated registration fees"

Submission Requirements & Process Updates

The guidance provides clarified submission pathways depending on whether a business is U.S.-based or foreign:

For U.S. Businesses:

• Submit an MDUFA Small Business Request SBR via the CDRH Portal
• Include the most recent signed Federal (U.S.) income tax return for the business and each U.S. affiliate
• If foreign affiliates exist, provide National Taxing Authority Certifications for each one

For Foreign Businesses:

• Submit an MDUFA Foreign SBR through the CDRH Portal
• Obtain and include a completed National Taxing Authority Certification, showing gross receipts/sales (in local currency and USD)
• Include U.S. tax returns for any U.S. affiliates

Plan Your Request Strategy Accordingly: Requests for FY2026 opened on August 1, 2025 and will be accepted through July 31, 2026. For registration fee waivers, the deadline is October 31, 2025.

Benefits of Qualifying

FDA user fees are substantial, especially for early-stage or first-time submitters. Small business status can result in:

• Up to 75% off standard fees for premarket submissions
• Full fee waiver for a business's first PMA, BLA, PDP, or PMR
• Registration fee waived ($6,493 in FY2025) if financial hardship is proven

*NOTE: Registration waivers are rarely granted and usually require proof of active bankruptcy.

Important Considerations & Best Practices

1. Annual renewal is required: Small Business Determinations are valid for one fiscal year only (Oct 1 – Sept 30)
2. Include all affiliates: Omission of affiliates or misreporting of revenue can result in penalties
3. First-time waivers are one-time: Once used, the "first premarket" waiver cannot be reused, even across company acquisitions
4. Documentation must be complete and timely: Submit at least 60 days before the fee is due

Summary

The FDA updates to the Medical Device User Fee Small Business Qualification and Determination guidance offers clear pathways for both U.S. and foreign device companies to reduce their FDA regulatory costs. As fee schedules continue to rise, small businesses should leverage this opportunity to reduce upfront expenses—especially when launching their first products in the U.S.

Next Steps for Manufacturers → Evaluate your eligibility, gather the required documentation, and submit your SBD request through the FDA CDRH Portal. Early action ensures you receive fee reductions in time for upcoming submissions in FY2026.