According to the United States Food and Drug Administration (FDA), all registered medical device establishments located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s products.
Each foreign establishment may designate only one U.S. agent.
The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent.
The responsibilities of the U.S. agent are limited and include:
Please note that the U.S. agent has no responsibility related to:
In addition to U.S. Agent services, CENIT can also assist you with the following:
FDA Registration and Renewal
FDA UDI and GUDID Compliance Solutions
Master File Submission
FDA registration for establishment and products - Registration updates - Medical device reporting - U.S. regulatory contact - UDI regulatory contact
Assignment and registration of device configurations:
- Single device configuration $100
- Group of 10 device configurations $500
- Group of 25 device configurations $1000
- More than 25 device configurations, contact for pricing
All FDA related correspondence and/or documents received and/or delivered on behalf of client as a registered U.S. Agent will be billed at our hourly rate plus applicable shipping costs
* Fees are updated for 2023 and may be subject to changes.