FDA US Agent – Overview of Responsibilities

FDA US Agent –¬†Overview of Responsibilities

A FDA US Agent serves many important roles for a foreign manufacturer or distributor. A FDA US Agent is required for any foreign company – medical device, drug, dietary supplement, food (juice, seafood, canned (acidified) food, conventional food), or animal products. Unlike other countries a FDA US agent, who is a private individual or company, does not hold any registrations for the foreign company. That is to say it is not a Registration Holder as used in other regulatory systems.

One of the primary roles of a FDA US Agent is to receive communications, particularly import holds or refusals, from the FDA. This may sound ordinary, but FDA communications are extremely time sensitive. In many cases the FDA provides less than seven (7) days to respond to a notice. A responsible FDA US Agent will not only provide the notice to the foreign facility in a timely fashion, but should be able to advise on options to respond.

This is what makes our firm unique. Our attorneys acts as FDA U.S. Agents and can easily respond to routine questions from the FDA as well as provide counsel on the best approaches to avoid an import refusal or Import Alert.

The responsibilities of the FDA U.S. agent typically only 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 United States;
  • Assisting FDA in scheduling inspections of the foreign establishment; and
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Contact our Washington D.C. or Charlotte office to learn more about our U.S. Agent representation.