US Designated Agent Services

US Designated Agent Services

The FDA requires the use of a U.S. Agent to the Food and Drug Administration for all companies and manufacturers that do not have a presence in the United States. A U.S. Agent to The Food and Drug Administration (FDA) must be a resident of the United States, or have a physical place of business in the United States. A U.S. Agent to the FDA may not use a Post Office address, or answering service, without a physical presence; rather, a U.S. agent to the FDA must answer phone calls, or have employees who are available throughout a business day.

If you are a foreign based manufacturer*, and do not have a facility in the U.S., you will not be able to register your facility, list your products, or submit your FDA marketing authorization applications, unless you designate a U.S. Agent to the FDA. mdi Consultants, Inc., acting as your U.S. Agent to the U.S. Food and Drug Agency (FDA), negates the necessity and expense of having a facility in the United States

Because the U.S. market presents an attractive business opportunity for many foreign companies in the medical device, pharmaceutical, cosmetic, and dietary supplement fields, having a U.S. Agent in the FDA is extremely important.

The responsibilities of U.S. Agent include:
- assisting FDA in communications with the foreign establishment
- responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States
- assisting FDA in scheduling inspections of the foreign establishment
- 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