Basic Information About U.S. Agents
WHAT IS THE DEFINITION OF A FOREIGN FACILITY?
The final rule states that all foreign establishments of medical devices, human and animal drugs, and biologicals who manufacturer any of these products must have a designated agent in the USA:
- Medical device manufacturers
- Human drug manufacturers
- Animal drug manufacturers
- Biological manufacturers
WHAT WILL YOUR U.S. AGENT DO?
Based on the responsibilities outlined by the U.S. FDA, a U.S. Agent is responsible for the following activities
- U.S. Agent Program for Pharmaceutical / Medical Device Manufacturers
- Keep a physical office in the USA
- Provide updates of the establishment registration and product listing
- Be responsible to provide communications between the FDA and the Company, ie. upcoming inspections of the foreign site
In addition to the responsibilities of the U.S. Agent, the foreign facility has the following responsibilities:
- Provide their Agent an update of changes to the Establishment registration (e.g. address, change in ownership)
- Notify their Agent of any new products or changes to already listed products (e.g. dropping them from the product line)
- Notify their Agent of changes in telephone numbers, fax numbers or email addresses.