FDA MDUFA Small Business Benefits: eligibility and reduced fee options

The Medical Device User Fee Amendments (MDUFA) authorize the FDA to collect user fees for certain types of medical device submissions and for the annual establishment registration.
For small companies in the sector, these costs can be reduced—or in some cases completely waived—through the Small Business Determination (SBD) Program managed by the Center for Devices and Radiological Health (CDRH).

Determining small business status

To access reduced fees, a company must submit a Small Business Request (SBR). Through this process, the FDA verifies whether the business meets the SBD Program requirements.
Eligibility depends on the company’s annual gross receipts or sales and applies to specific types of CDRH submissions.

Reduced fees for eligible businesses

Small businesses with gross receipts or sales of $100 million or less may qualify for reduced fees on the following submissions:

• Premarket Notification (510(k))
• De Novo request
• Premarket Applications (Premarket Approval Application – PMA, Biologics License Application – BLA, Product Development Protocol – PDP, Premarket Report – PMR)
• PMA/BLA supplements and PMA annual reports
• 513(g) request for classification information

The reduction applies only if the company is officially qualified through the SBD Program.

Fee waivers for the first major application

Businesses with gross receipts or sales of $30 million or less may be eligible for a full fee waiver on their first PMA, PDP, PMR, or BLA submission.
This waiver applies exclusively to the first qualifying submission after SBD Program approval.

Fiscal year 2026 annual establishment registration fee waiver

Starting in Fiscal Year 2026, certain small businesses may also qualify for a waiver of the
Annual Establishment Registration Fee if:

• The company and its affiliates have gross receipts or sales of $1 million or less.
• Paying the fee would represent a financial hardship (e.g., active bankruptcy with documented proof).
• The company can provide proof of prior year’s payment of the registration fee.

This measure is intended to support very small businesses facing significant financial challenges.

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