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 U.S. or maintain a place of business in the U.S. US FDA agent 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 normal 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. The fees for LMG to act as your US FDA agent for your food facility is USD 349/year.

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. LMG Fees for US FDA agent service for a medical device establishment is USD 449/Year

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. Our fees for US FDA Agent service is USD 649/year, which includes FDA registration SPL submission.

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 not mandatory for Cosmetic establishments, US FDA agents cannot open VCRP accounts on behalf of the manufacturer, but US FDA agents can assist the manufacturer in filing product ingredients with US FDA.

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

  • Filing cosmetic formulations with US FDA
  • Complying cosmetic labeling with US FDA regulations