USFDA Med Dev Guidance: Medical Device User Fee Small Business Qualification and Determination

Sharan Murugan
Jul 31
2 min read

In July 2025, the USFDA published a revised guidance titled "Medical Device User Fee Small Business Qualification and Determination",which offers detailed instructions for industry, FDA staff, and foreign governments on how small businesses can qualify for reduced user fees or waivers under the Medical Device User Fee Amendments (MDUFA) program. This update replaces the 2018 guidance and reflects the FDA’s ongoing efforts to make regulatory pathways clearer and more accessible to innovators worldwide.

Medical device user fees can be significant, especially for start-ups and small companies developing new devices. To encourage innovation, MDUFA allows businesses that qualify as small businesses to pay:

✅ Lower application fees

✅ A one-time waiver for the first premarket application/report fee

✅ A waiver of the annual establishment registration fee in cases of financial hardship

The new guidance explains exactly how to request these benefits — and what documentation is required.

Who can qualify

The guidance sets different thresholds for different types of fee relief:

Benefit	Definition of small business (incl. affiliates)	Notes
Reduced application fees	≤ $100 million in gross receipts/sales	Applies to PMAs, 510(k)s, De Novo, BLAs, and others
First premarket application/report fee waiver	≤ $30 million	Only once, for the first PMA/BLA/PDP/PMR
Registration fee waiver (financial hardship)	≤ $1 million	Applicant must also show financial hardship (e.g., bankruptcy)

Importantly, the definition of “affiliate” is broad: businesses under shared control must combine their revenue when calculating eligibility.

How to apply

The guidance explains step-by-step processes depending on whether your business is:

Headquartered in the U.S.
Headquartered abroad
A foreign affiliate of a U.S. firm
A national taxing authority supporting foreign applicants

For U.S. businesses:

✅ Complete a MDUFA Small Business Request (SBR) in the CDRH Portal

✅ Include your latest signed Federal (U.S.) income tax return and those of affiliates

✅ Obtain an Organization ID number (Org ID)

For foreign businesses:

✅ Use the MDUFA Foreign SBR form

✅ Have your national taxing authority complete the required certification, including official seal, revenues in local currency and USD, and exchange rate

✅ Submit via the CDRH Portal

For financial hardship waivers, applicants should also provide evidence of active bankruptcy and prior registration fee payment.

What are the benefits

If approved, a small business may:

Pay reduced fees for PMAs, BLAs, PDPs, 510(k)s, De Novo requests, annual reports, and more
Receive a one-time waiver for the first premarket application/report fee
Obtain a registration fee waiver (once) if paying the fee would cause financial hardship

FDA’s decision on small business qualification applies for one fiscal year only (October 1 – September 30). Businesses must apply annually to keep benefits.