FY2027 FDA Device Establishment Registration Fee: $13,785

FDA's annual medical device establishment registration fee for fiscal year 2027 (October 1, 2026 to September 30, 2027) is $13,785 (Federal Register, July 30, 2026, doc 2026-15335). There is no small-business reduction for this fee. The establishment pays FDA directly through the Device Facility User Fee site and must pay before completing its annual registration.

How to pay

• Create a payment order on FDA's user fee site and keep the payment identification number (PIN)
• Then register or renew in FDA's Device Registration and Listing Module
• US Agent Desk never pays or advances FDA fees

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.