FDA Medical Device Annual Establishment Registration Fee
Every medical device establishment that must register with FDA pays an annual establishment registration fee set each fiscal year under MDUFA. There is no small-business reduction for this fee. It is paid to FDA through the Device Facility User Fee website before the establishment completes its annual registration between October 1 and December 31.
Who pays
- Most establishments that must register under 21 CFR Part 807, including foreign manufacturers, contract manufacturers, specification developers, relabelers and repackagers
- The fee is per establishment, not per device
How to pay
- Create an order on FDA's Device Facility User Fee (DFUF) website
- Pay by card, ACH or wire and record the Payment Identification Number (PIN) and Payment Confirmation Number (PCN)
- Enter them in FDA's Device Registration and Listing Module when you register
Our role
- Your company pays this fee directly to FDA. It is not part of our price
- We remind you before the window opens and check that the fee and the registration are both complete
Related: FDA renewal deadline calendar · Do I need a U.S. Agent? · US Agent Desk pricing
General information, not legal advice. Last reviewed October 21, 2026.