All medical device companies located outside the United States are required to have a registered point of contact within the USA under federal law 21 CFR 807.40.
This point of contact is known as the US Agent. More specifically, the US Agent acts
as a conduit between the FDA and your firm. The US Agent has four specific responsibilities:

1. Assisting the FDA in communication with foreign establishment
2. Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States
3. Assisting the FDA in scheduling inspections of the foreign establishment
4. Should the FDA be unable to contact the foreign establishment directly or expeditiously, the FDA may provide information or documents to the
   United States agent - an action deemed equivalent to providing the same information or documents to the foreign establishment.

Our US Agent Service also includes managing FDA forms and documents. This ensures that there are no errors, and that we have the most recent copies of these important documents when the FDA calls.

• We are set up to represent your best interests in the US market
• As your US Agent, we operate as the official conduit between the FDA and
  your firm
• We keep all files up to date and error-free