FDA have announced their user fess for financial year 2026. The fees will apply from 1st Oct 2025 until 30th Sep 2026.
The FDA Annual Establishment Registration Fee stands at $11,423.
Under the Small Business Determination (SBD) Program, small businesses able to demonstrate financial hardship according to FDA, the FDA has discretion to waive the annual establishment registration fee. This does not apply to the initial registration.
Small businesses demonstrating financial hardship as determined by the FDA may qualify for this waiver. For further details, refer to the Small Businesses section on the FDA’s official page.
Link to the FDA page: https://lnkd.in/dEkSWKnF