The U.S. Food and Drug Administration (FDA) requires foreign establishments that manufacture, process, pack, or store FDA-regulated products to have a designated U.S. Agent. The U.S. Agent serves as a point of contact between the FDA and the foreign establishment. Here is an overview of the FDA Agent service:
1. Purpose of the U.S. Agent: The U.S. Agent is responsible for facilitating communication between the FDA and the foreign establishment. They act as a representative of the foreign establishment and assist in various regulatory matters, including FDA inspections, import-related issues, and compliance with FDA regulations.
2. Selection of a U.S. Agent: The foreign establishment is responsible for selecting a qualified individual or organization to serve as its U.S. Agent. The U.S. Agent must have a physical address in the United States and be available during normal business hours to communicate with the FDA.
3. Responsibilities of the U.S. Agent: The specific responsibilities of the U.S. Agent may vary depending on the nature of the foreign establishment and the FDA-regulated products involved. Some common responsibilities include:
– Serving as the primary contact for communication with the FDA on behalf of the foreign establishment.
– Assisting with FDA registration and listing requirements.
– Facilitating communication during FDA inspections of the foreign establishment.
– Helping to address FDA inquiries, requests for information, or enforcement actions.
– Maintaining accurate and up-to-date records related to the foreign establishment’s FDA compliance.
4. Designation of U.S. Agent: The foreign establishment designates its chosen U.S. Agent by including their information in the appropriate sections of FDA registration forms, such as the Establishment Registration and Device Listing.
5. Change of U.S. Agent: If there is a change in the designated U.S. Agent, the foreign establishment must promptly update its FDA registration information to reflect the new U.S. Agent’s details.
It’s important to note that the U.S. Agent does not have the authority to make regulatory decisions on behalf of the FDA or the foreign establishment. They serve as a liaison and facilitate communication between the two parties.