If you are a foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States you must identify a United States agent (U.S. agent) for your establishment.
- We can represent you as that agent for a nominal annual fee.
- We can act as your official correspondent with the FDA as part of this arrangement.
As required, we have our primary place of business in the United States and we are available by phone during normal business hours.
- Assist your foreign business with communications between you and the FDA.
- Respond to questions concerning your foreign establishment's devices that are imported or offered for import into the United States,
- Assist you and the FDA in scheduling inspections of your foreign establishment,
- and if the FDA is unable to contact your foreign establishment directly or expeditiously, we will accept information or documents for you as your U.S. agent, and provide them to you as soon as possible.