US FDA Agent service and Fees

US FDA Agent service to Foreign Food Facilities

US FDA Agent is a mandatory requirement for foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. The US FDA agent must either reside in the USA or maintain a place of business in the USA. US FDA agents cannot use a post office box as an address. US FDA agent must be available to answer the phone or have an employee available to answer the phone during regular business hours. The FDA agent acts as a communications link between US FDA and the food facility for both routine and emergency communications unless the facility designates a different emergency contact. Please visit our fee page for the updated fee schedule at FDA Registration Fees

As your FDA Food Agent, Liberty Management Group will assist you in

  • food facility Registration
  • Issue prior notice to US FDA
  • Complying food product labeling with FDA requirements

US FDA Agent for Medical Device Establishment

Any foreign medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a U.S. FDA agent for that establishment. Information about a foreign establishment's US FDA agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one FDA agent. The foreign establishment may also designate its US FDA agent as its official correspondent. The US FDA agent has no responsibility to report adverse events under the Medical Device Reporting regulation. Please visit our fee page for the updated fee schedule at FDA Registration Fees

The responsibilities of the US FDA agent are limited and include:

  • Assisting FDA in communications with the foreign establishment
  • Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the US
  • Assisting FDA in scheduling inspections of the foreign establishment
  • If FDA is unable to contact the foreign establishment directly, FDA may provide information or documents to the US FDA agent

As your U.S. FDA Agent, Liberty Management Group will assist you in

  • Establishment Registration
  • Medical Device Listing
  • FDA 510 K Submission
  • Official correspondent requirements
  • Complying medical device labeling with FDA regulations

US FDA Agent for Drug Establishment

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must register with the FDA and identify a U.S. FDA agent. All drugs imported into the United States must be listed by the foreign firm or its designated US FDA agent. Please visit our fee page for the updated fee schedule at FDA Registration Fees

As your US FDA Agent, Liberty Management Group will assist you in

  • Drug Establishment Registration with US FDA
  • Drug listing with US FDA
  • Obtaining labeler code from US FDA
  • Complying drug labeling with US FDA regulations

US FDA Agent service to Cosmetic Manufacturer

US FDA agent is mandatory for foreign cosmetic establishments. US FDA agent can help you with cosmetic establishment registration and product listing with FDA.

As your US FDA Agent, Liberty Management Group will assist you in

  • Cosmetic establishment registration
  • Cosmetic product listing
  • Cosmetic label compliance