MDUFA V Medical Device User Fees for Fiscal Year 2026

1. Key takeaways

The medical device user fee rates for fiscal year 2026, which runs from October 1, 2025 to September 30, 2026, are published in Medical Device User Fee Rates for Fiscal Year 2026 (90 FR 35895, 2025-07-30). Under that notice, the annual establishment registration fee is USD 11,423 and the standard 510(k) fee is USD 26,067, with a small business fee of USD 6,517. These figures, together with the full FY2026 rate table reproduced below, form the budget baseline for any company registering establishments or filing premarket submissions with FDA during this fiscal year.

• Source document: Medical Device User Fee Rates for Fiscal Year 2026, 90 FR 35895, published 2025-07-30.
• Annual establishment registration fee for FY2026: USD 11,423, with no small business reduction.
• 510(k) fee for FY2026: USD 26,067 standard; USD 6,517 for small business.
• The rates apply from October 1, 2025 through September 30, 2026.

2. Legal basis

The FY2026 rates rest on the user fee authorization in the FD&C Act and on the annual Federal Register notice in which FDA computes the year’s rates from the statutory revenue target. The authoritative references are listed below, followed by the complete FY2026 rate table in United States dollars.

FY2026 rate table (standard and small business, in United States dollars):

3. Expert insights

Insight 1: The annual establishment registration fee has no small business reduction.

In the FY2026 table, the review-type fees, including the 510(k), 513(g), PMA, and De Novo fees, all carry a small business column with reduced rates. The annual establishment registration fee, by contrast, exists only at the standard rate of USD 11,423. This is the most commonly miscalculated item in user fee budgeting: small business qualification does not reduce the annual establishment registration fee. A company that qualifies as a small business for its 510(k) submission should still budget the full standard amount for registering and re-registering its establishments each fiscal year, and financial plans that assume a discounted registration fee will come in short.

Insight 2: The rates operate on a fiscal year cycle and switch on October 1.

The FY2026 rates apply from October 1, 2025 to September 30, 2026. A submission filed at the end of September and one filed in early October are governed by two different sets of rates. A submission that spans the fiscal year boundary is charged at the rate applicable to the fiscal year at the time of submission. This matters for companies that plan filings in the August to October window, where a small shift in the filing date can move the payable fee from one fiscal year’s schedule to the next, and the schedule used should be identified explicitly in the budget before the submission is filed.

Insight 3: Payment of the fee is unrelated to the review outcome.

FDA states officially that the payment of a premarket review fee is not related in any way to the FDA’s final decision on a submission. The fee is a prerequisite for acceptance into review, not consideration paid for a favorable outcome. Companies should therefore treat user fees as a fixed cost of market entry that is incurred regardless of the eventual decision, and should keep fee payments out of any calculation of expected approval value. This framing also disciplines internal communication: fees buy a review, not a result.

Insight 4: The revenue target is the statutory adjustment variable behind rate changes.

According to 90 FR 35895, the FY2026 fee revenue target is USD 366,486,300. The rates are calculated under a statutory formula based on the revenue target and estimates of submission volume, which is the mechanical reason the rates change from year to year. Because both inputs move annually, no rate should be carried forward without checking the current fiscal year’s notice, and budget cycles should be synchronized with the publication of the annual rate document rather than with the calendar year.

4. Practical recommendations

The measures below align fee budgeting and payment records with the fiscal year structure of the MDUFA V rates.

• Prepare budgets by fiscal year, and charge cross-fiscal-year submissions at the rate applicable to the fiscal year at the point of submission.
• For small business budgets, apply the small business rates, but budget the annual establishment registration fee at the full standard USD 11,423.
• Treat fees as a prerequisite for acceptance, not as part of any expectation of approval.
• Maintain a fee ledger recording the applicable fiscal year, the rate applied, and the payment date for every payment.
• Around July each year, watch the Federal Register for the new annual rate notice and adjust budgets in advance.

5. Verification checklist

Confirm each item below before finalizing the fee budget or filing a fee-bearing submission in FY2026.

• □ The applicable fiscal year has been confirmed (FY2026: 2025-10-01 to 2026-09-30).
• □ The annual establishment registration fee has been budgeted at USD 11,423.
• □ The 510(k) fee has been budgeted at USD 26,067, or USD 6,517 for small business.
• □ It has been confirmed that payment of fees is unrelated to the review outcome.
• □ The fee ledger records the applicable fiscal year and the payment date.
• □ A watch point has been set for the publication of the next fiscal year’s rate notice.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com