Medical Device Annual Registration Fees for 2026: What to Expect

Understanding MDUFA V Fees

The Medical Device User Fee Amendments (MDUFA V), reauthorized for FY2023–FY2027, authorize FDA to collect user fees from medical device companies to fund the premarket review process and related activities. MDUFA fees are established annually by FDA and published in the Federal Register each August.

MDUFA V fees fall into several categories:

• Annual establishment registration fee: Paid by every device establishment (domestic and foreign) that registers with FDA
• Premarket application fees: Paid when submitting PMAs, 510(k)s, and other premarket submissions
• Small business qualification: Reduced premarket submission fees for qualifying small businesses

For FY2026 (October 1, 2025 – September 30, 2026), the key fees are:

The Annual Registration Fee

The $7,653 annual establishment registration fee applies to every device establishment that registers with FDA, including:

• Domestic manufacturers
• Foreign manufacturers exporting to the U.S.
• Contract manufacturers
• Contract sterilizers
• Specification developers
• Reprocessors of single-use devices

This fee must be paid before your annual registration is processed. The registration period runs October 1 through December 31 each year. FDA sends fee invoices starting in September. If you do not pay the fee, your registration will not be active, and your devices may be refused entry or subject to enforcement action.

How to Pay the Registration Fee

1. Receive your invoice: FDA sends fee invoices electronically through the MDUFA fee system. Check your FDA account and the email associated with your registration.
2. Pay via pay.gov: FDA accepts payment through pay.gov using ACH bank transfer, debit card, or credit card. International wire transfers may also be accepted.
3. Link payment to registration: After payment, proceed to the FURLS system to complete or renew your device establishment registration.
4. Verify active status: After submission, confirm that your registration shows as active in FURLS.

Payment must be completed before the December 31 deadline. Late payments will delay your registration, and your establishment will not appear as actively registered in FDA's systems.

Small Business Qualification

To qualify for small business fee reductions on premarket submissions (not the annual registration fee), your company must meet FDA's criteria:

• Gross receipts or sales of no more than $100 million for the most recent tax year
• Submit a Small Business Qualification request to FDA before October 1 of the fiscal year
• Provide documentation of gross receipts (tax returns or audited financial statements)

Small business status must be re-qualified each fiscal year. If your company grows beyond the $100 million threshold, you lose the qualification for the following fiscal year.

Budgeting for FDA Device Compliance

When budgeting for FDA device compliance, consider all costs:

• Annual registration fee: $7,653/year per establishment
• U.S. Agent fees (foreign facilities): Varies by provider. Assurentry offers device U.S. Agent services starting at $249/year.
• Premarket submission fees: Varies by submission type (see table above)
• Third-party service fees: Registration assistance, listing management, compliance consulting