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Fee planning/US
510(k) small business fee: how to check the FY2026 reduced rate
Check the FDA FY2026 510(k) standard fee, small business fee, and Small Business Determination steps before paying.
Direct answer
For FDA fiscal year 2026, the published 510(k) standard fee is $26,067 and the small business fee is $6,517. These numbers run from October 1, 2025 through September 30, 2026, so teams should verify the current FDA fee page again before payment.
The key step is timing. A company needs its own Small Business Determination before using the reduced fee. Do not wait until the payment step if the budget depends on the lower fee.
Use this if
Reader
A founder or finance owner budgeting a 510(k) submission
Trigger
The team is preparing a submission budget or payment timing
Blocked decision
Whether to apply for Small Business Determination before paying the user fee
Useful output
A current fee and timing checklist tied to FDA FY2026 rules
Do these first
- Confirm the current FDA fiscal-year fee table.
- Check whether the applicant and affiliates fit the small-business rules.
- Gather tax and affiliate documentation before the payment deadline.
- Keep the Small Business Determination letter with the submission payment record.
What to collect before you ask for help
- Applicant legal entity and affiliate list.
- Most recent tax documentation or foreign certification documents.
- FDA organization ID and portal access owner.
- Submission type and expected payment date.
Common mistakes
- Using old fee numbers from a prior fiscal year.
- Assuming one company's small-business status transfers to another applicant.
- Paying first and trying to fix the fee status later.
Public sources to start with