U.S. Agent to the Food and Drug Administration
Representing Medical Device, IVD Manufacturers, the Pharmaceutical, Food, and Cosmetic Industry
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 may not use a Post Office address, or answering service, without a physical presence; rather, a U.S. agent 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.. mdiConsultants, 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 to 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.
*The Food and Drug Administration requirement for all foreign establishments, companies, and manufacturers is that Medical Device, Human Drug, Animal Drug, and Biological companies and manufactures have a designated agent in the USA:
Why select mdiConsultants as your U.S. Agent to the FDA?
For over 45 years, mdi Consultants has successfully represented foreign based companies, not just as their FDA U.S. Agent; but, as their FDA Consultant for all areas of FDA approvals. As a U.S. Agent, mdi has always fulfilled all the responsibilities required of a U.S. Agent, under the law.
mdi Consultants takes great pride on being an effective liaison between the client company and the FDA. We assist with all communications between the Agency, and your company, including the scheduling and negotiation of FDA inspections, import detention issues, and all compliance questions that may come your way.
Why Else Do You Need a U.S. Agent?
Identification of and contact information for a U.S. agent is required for all foreign manufacturers when they register and list with FDA.
All Pre-market Applications (PMA) for class III devices submitted by an applicant that does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative (U.S. Agent) residing or maintaining a place of business in the U.S. and must identify the representative’s name and address.
To facilitate timely communication, US FDA recommends that a U.S. representative is included for all submission types .