FDA Medical Device Registration Fee for FY 2026: Small Business Waiver Guide

The FDA medical device registration fee for FY 2026 is set at $11,423, a 23% increase from FY 2025. This fee applies to all medical device companies registering with the U.S. Food and Drug Administration (FDA) from October 1, 2025, to September 30, 2026. Small businesses renewing their registration may qualify for a small business waiver under the Small Business Determination (SBD) Program if paying the fee causes financial hardship, but this waiver does not apply to initial registrations. This guide covers the fee increase, what’s new, waiver eligibility, how to apply, and impacts on existing and new medical device manufacturers.

FDA Medical Device Registration Fee Increase for FY 2026

The annual establishment registration fee, due between October 1 and December 31, is $11,423 for FY 2026, up from $9,280 in FY 2025. This $2,143 increase (23%) reflects adjustments for inflation, FDA workload, and improved review processes.

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What’s New for FY 2026 Medical Device Registration

The small business waiver for the annual registration fee, introduced in FY 2025, continues but applies only to renewals, not initial registrations. The FDA’s updated guidance, “Medical Device User Fee Small Business Qualification and Determination Guidance” (July 31, 2025), streamlines the process with:

• Form FDA 3602N: A single form for U.S. and foreign businesses.
• Clear Hardship Criteria: Examples like active bankruptcy.
• Foreign Business Rules: Support for those without a tax authority (e.g., IRS equivalent).
• Non-Transferable Waivers: Only for renewals, not transferable during sales.

The FDA adjusted fee calculations to account for increased waiver usage, ensuring funding for regulatory activities.

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Who Qualifies for the FDA Small Business Waiver?

The FDA may waive the $11,423 fee for renewals (not initial registrations) for small businesses under the SBD Program that demonstrate financial hardship. Eligibility requires all three criteria:

1. Small Size: Total sales/revenue of $1 million or less in the latest tax return, including affiliates.
2. Financial Hardship: Proof like an active bankruptcy petition (debts not cleared).
3. Prior Registration: Previous FDA registration and fee payment under the same owner.

Important: The waiver is not available for first-time registrants and must be renewed annually. Foreign businesses without a tax authority must submit equivalent financial documents.

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How to Apply for the FDA Registration Fee Waiver

Small businesses must apply via the FDA’s online User Fee System, with electronic submissions mandatory since November 1, 2024. Follow these steps:

1. Prepare Documents:
   • Complete Form FDA 3602N (waiver section).
   • Submit a tax return showing $1 million or less in sales.
   • Provide hardship proof (e.g., bankruptcy documents).
   • Include prior registration and payment proof (e.g., FDA emails).
   • Have your FDA Organization ID ready.
2. Submit Application:
   • Log into the FDA User Fee System.
   • Apply between August 1, 2025, and October 31, 2025, at least 60 days prior to the fee due date.
3. Await FDA Decision:
   • If approved, receive a Small Business Decision number for a fee waiver during renewal.
   • Decisions are final.

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Impact on Medical Device Manufacturers

Good News for Existing Small Manufacturers

Existing manufacturers with $1 million or less in sales, facing financial hardship (e.g., active bankruptcy), and with prior FDA registration benefit significantly. The small business waiver eliminates the $11,423 renewal fee, reducing costs and supporting compliance. The streamlined Form FDA 3602N simplifies the application process.

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Challenges for Larger Businesses and First-Time Registrants

Manufacturers with over $1 million in sales or those registering for the first time face higher costs. The 23% fee increase to $11,423 adds financial strain, especially for companies with multiple establishments. First-time registrants, regardless of their size, are not eligible for the waiver and must pay the full fee, which may pose a significant challenge for new market entrants with limited financial resources.

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