US Agent Service

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.

Responsibilities of a U.S. agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include: USFDA

USFDA Corp 7 STEPS RULE FOR CUSTOMERS

  1. USFDA Corp Registration. It's Free
  2. Fill the application Form
  3. USFDA Corp Account Manager contacts you
  4. All relevant documents are collected from your team required by FDA
  5. USFDA Corp services & FDA charges financial quote is provided
  6. On financial quote approval your FDA Registration is completed as per the schedule provided by USFDA Corp
  7. 24x7 x 365 Free Support by USFDA Corp

Have a question or need a custom quote?

Our consultants are waiting for your call for your company FDA registration requirements.
+1 (909) 280 0838