The Spain-US Chamber of Commerce Provides the Service to Act As a U.S. Agent of the FDA

The Spain-US Chamber of Commerce provides the service to act as a U.S. agent of the Food and Drug Administration (FDA). A foreign facility who plans to export must provide an FDA registration and designate a U.S. agent with a permanent physical presence in the United States. This requirement also applies to companies that export medical devices, cosmetics and pharmaceutical drugs to the United States. As a U.S. FDA agent, the Spain-U.S. Chamber of Commerce handles the required registration/renewal process and provides its members with the necessary information related to import requirements enforced by the FDA, including updates when changes occur.

In its role as a U.S. agent, the Spain-U.S. Chamber of Commerce serves as a communication liaison between the FDA and the foreign facility. The U.S. agent is the entity that the FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.