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> 【FDA】FY 2026 Official Fee Standards Announced, Opportunity to Apply for Registration Fee Waiver is Here!

【FDA】FY 2026 Official Fee Standards Announced, Opportunity to Apply for Registration Fee Waiver is Here!

On July 30, 2025, the U.S. Food and Drug Administration (FDA) announced the medical device user fee standards for the 2026 fiscal year (October 1, 2025 to September 30, 2026):
Annual Establishment Registration Fee: $11,423
FDA 510K Application Fee (Premarket notification submission Fee): $26,067 (if approved for small business qualification, the 510K application fee is reduced to $6,517).
Details of the fees are as follows:

User Fees for FY 2026 October 1, 2025, through September 30, 2026. Annual Establishment Registration Fee: $11,423 Application Fees:

In recent years, the fee standards have been increasing year by year, but please note that:
In the 2026 fiscal year, the FDA may, under the Small Business Determination (SBD) program, waive the annual registration fee (excluding initial registration) for small businesses that pass the qualification review, provided that these businesses can prove that paying the fee would cause them financial hardship, which needs to be determined by the FDA.

Conditions for applying for the annual registration fee waiver:

The company's annual turnover or sales do not exceed $1 million
The company can prove that there is financial difficulty in paying the fee
Having proof of payment of the registration fee for the previous year

Enterprises that meet all the above three conditions may be exempted from the annual registration fee.

How to apply for the annual registration fee waiver?
SUNGO International Development Department will provide you with guidelines and declaration services. If you need it, please contact us!