The FDA has issued its updated final guidance for Small Business Qualification and Determination under the Medical Device User Fee Amendments (MDUFA), effective for Fiscal Year 2026. This update, released on July 31, 2025, is essential reading for U.S. and foreign medical device companies seeking to reduce or waive costly FDA fees.
Why It Matters
For startups and small businesses operating on lean budgets, FDA user fees can be a heavy lift. This guidance lays out how qualifying as a “small business” can mean significant cost savings, including:
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Reduced application fees for companies with ≤ $100 million in gross receipts/sales.
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A one-time waiver of your first premarket application/report fee if you’re under $30 million in revenue.
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A registration fee waiver for companies with ≤ $1 million in revenue—granted in cases of demonstrated financial hardship (think active bankruptcy).
Who Needs to Pay Attention?
This guidance is applicable to:
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U.S.-based companies – Must submit their most recent signed federal tax return and any affiliate documentation.
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Foreign companies – Must obtain a National Taxing Authority Certification and submit it via the CDRH Portal.
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National Taxing Authorities – Must certify foreign entities’ gross receipts and affix an official seal.
Important FY26 Deadlines
- Small Business Requests (SBRs) for FY26 are accepted starting August 1, 2025, and must be submitted at least 60 days before any user fee is due.
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For registration fee waivers, the deadline is October 31, 2025.
Pro Tips from RQMIS
- Start early. The small business determination is not retroactive—apply before submitting any user fee-triggering documents.
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Don’t risk it. Submitting false information in your SBR? That could lead to criminal penalties, fee suspensions, or worse.
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Use the FDA CDRH Portal and have your Org ID ready. (You’ll need it for every application.)