Device Registration & U.S. Agent Service Fees for FY2024 (October 1, 2023-September 20, 2024)*

Domestic registration
Foreign Registration (with US Agent)
Update of registration information
*Please note that effective October 1, 2023 – September 30, 2024 (FY 2024), the FDA user fee is $7,653. Note: Fees are per facility and subject to change without notice. The device registration fee includes: $1,100 service fee + $7,653 government registration fee that is submitted to FDA.
Registration process
  1. Complete the Registration Form
  2. Receive an automatic email confirmation, including the completed form
  3. Receive an email confirming FDA device registration with the submission
FDA facility registration is a flat-fee service, and does not create an attorney-client relationship. For any legal regulatory questions or issues, please contact us at to setup a complimentary initial consultation.
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