DCG provides U.S. Agent services and/or Official Correspondent to medical
device manufactures located outside of the U.S. and import into the U.S.
DCG meets all FDA requirements as listed below.
To receive additional information on DCG's U.S. Agent services and fee data
complete the U.S. Agent Information Request Form below.
Any foreign establishment engaged in the manufacture, preparation,
propagation, compounding, or processing of a device imported into the United
States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. agent is submitted
electronically using the FURLS system and is part of the establishment
registration process. 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 foreign establishment should
provide the name, address, telephone and fax numbers, and e-mail address of the
U.S. agent.
Responsibilities of a U.S. Agent
The 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. DCG is ready to answer the telephone 8 to 5 CST, Monday through Friday.
The responsibilities of the U.S. agent are limited and include:
Assisting FDA in communications with the foreign establishment, responding to
questions concerning the foreign establishment's devices that are imported or
offered for import into the United States, assisting FDA in scheduling
inspections of the foreign establishment and
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.
Please note that the U.S. agent has no responsibility related to reporting of
adverse events under the Medical Device Reporting regulation (21 CFR Part 803),
or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).
Please
note that we do NOT provide FDA Agent representation for FOOD companies.
