FDA Medical Device User Fee Small Business Qualification 2025 Guidance Update

The FDA Medical Device User Fee Small Business Qualification and Determination Guidance 2025 provides critical updates for medical device companies seeking fee reductions or waivers under the Medical Device User Fee Amendments (MDUFA). This guidance clarifies eligibility criteria and the application process for small business status, which can reduce regulatory costs and streamline market access.

What’s New in the 2025 FDA Small Business Fee Guidance?

The FDA updated its guidance on July 31, 2025, superseding the 2018 version to reflect current fee structures and qualification criteria. Key changes include clearer definitions of “small business” based on gross receipts thresholds, and detailed instructions for domestic and foreign companies on how to apply for fee reductions or waivers.

Key Updates in FDA Small Business Fee Waiver Guidance 2025

This updated guidance provides clearer details on:

• How the FDA assesses financial hardship for registration fee waivers

• What supporting documents are acceptable, including alternatives for businesses in countries without a national tax authority

• Defined revenue tiers that determine eligibility for reduced fees or waivers:

  • ≤ $100M – reduced application fees
  • ≤ $30M – waiver for first premarket submission
  • ≤ $1M – registration fee waiver with proof of financial hardship

• Introduction of Form 3602N, a single, streamlined application replacing Forms 3602 and 3602A

These changes aim to reduce administrative burdens and lower FDA costs for small medical device companies, including international firms, improving access to U.S. market pathways.

Why This Matters for Medical Device Companies

Qualifying as a small business can significantly reduce user fees associated with FDA submissions, such as 510(k)s, PMAs, De Novo requests, and establishment registrations. This reduces financial barriers for startups and smaller companies, encouraging innovation and faster patient access to new medical technologies.

How to Apply for the FDA Small Business Fee Waiver

1. Verify Eligibility: Ensure your business meets FDA small business size and hardship criteria.

2. Prepare Documentation: Gather financial records and proof of hardship, especially if in a tax-exempt jurisdiction.

3. Complete Form 3602N: Use the updated form for all fee waiver applications.

4. Submit to FDA: File the completed form before the deadline for fee consideration.

Learn More About FDA Medical Device Registration

For details on medical device classification and registration requirements, visit:

• Pure Global – US FDA Medical Device Registration

• Medical Device User Fee Amendments (MDUFA): Fees

• FDA Small Business Qualification Guidance