FDA US Agent services
for Medical Devices and more
US Agent Service
What a US Agent is?
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Responsibilities of a US agent
The medical device U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.
The responsibilities of the U.S. agent are limited and include:
assisting FDA in communications with the foreign establishment (medical device manufacturers).
responding to questions concerning the foreign establishment's medical devices that are imported or offered for import into the United States.
assisting FDA in scheduling inspections of the foreign medical devices establishment.
if FDA is unable to contact the foreign medical devices 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 medical devices establishment.
US FDA Agent Services For Foreign Companies
We offer US Agent services for foreign companies at the lowest fee.
The FDA US Agent plays important role for regulatory communication. The US Agent is the is the intermediary between the non US manufacturer and the FDA. Requesting an appointment with an Agent is a mandatory requirement for foreign companies. Our service applies to medical devices, food, and dietary supplements, in the United States. We also provide the establishment registration support.
We offer the FDA US Agent service to companies all over the world. Our rates have no extra costs, and our annual fee is low cost. We do not charge until registration is complete.
Is mandatory to have an US Agent?
Having a FDA US Agent is a mandatory economic operator for every Non-US manufacturer. We believe that entering the US market is a point of growth for any company. We are registered as US Agents with the FDA.
We are authorized to act as US Agent in:
- medical devices
Contact us for the best quote
Frequently asked questions
US Agent appointment timeline
The appointment with the US FDA agent takes only about 15 minutes, or if you prefer, we can do it by email. Once the foreign manufacturer has our data, they can include it in their regulatory filing or registration. Once the FDA notifies us that our data, as FDA Agent, has been used, we proceed to verification and send our invoice.
Can I change my current FDA US Agent?
The FDA US Agent can be changed at any time. The foreign manufacturer must change the data from the old FDA US Agent to the new one.
Can I obtain more services?
We also can help you being the point of contact to the FDA, helping you with the MDUFA fees, supporting in the Small Business designations and establishment registration
Do I have a price reduction if I contract more than one service?
If you hire our FDA US Agent service, plus UKRP and/or EU Authorized Representative, you will have a discount. Likewise, our prices are low cost and high efficiency.