The U.S. Agent acts as the FDA’s official liaison for foreign manufacturers, managing communication, inspection scheduling, and delivery of FDA notices. The role is limited to relaying information and does not extend to compliance, filings, or quality actions.
The FDA defines a U.S. Agent’s role in clear but limited terms. By regulation, the U.S. Agent must reside or maintain a place of business in the United States and be available to answer FDA calls during normal business hours. (A U.S. Agent cannot merely list a P.O. box or answering service; a live person must be reachable by FDA.) Within this scope, the agent’s primary responsibilities include serving as a communications link between the FDA and the foreign device manufacturer. In practice, this means the U.S. Agent handles critical informational exchanges on the company’s behalf. Key responsibilities include:
The U.S. Agent assists the FDA in communications with the foreign establishment. This involves receiving incoming correspondence (letters, emails, phone calls) from FDA offices and ensuring that inquiries, requests, or notifications are relayed promptly to the appropriate contacts at the foreign company. The agent may also initiate communication on behalf of the manufacturer when FDA needs a response, acting as the go-between to overcome time zone or language barriers.
If FDA officials have questions or require information about the foreign establishment’s devices that are imported into the U.S., the U.S. Agent is responsible for responding. For instance, FDA might ask the agent for clarification on a device listing or to provide documents for an import shipment; the agent would liaise with the manufacturer to gather the needed information and respond accordingly. In practical terms, the agent will gather information from the foreign manufacturer (about the device’s status, regulatory documentation, etc.) and provide answers to FDA in a timely manner. This ensures that routine questions – for example, about device listings, product details, or shipping documentation – can be addressed quickly through a U.S.-based contact.
The U.S. Agent helps coordinate and schedule FDA inspections of the foreign facility. When the FDA plans a foreign inspection, they will typically reach out to the U.S. Agent to arrange logistics. The agent communicates with both FDA officials and the foreign site’s management to find suitable inspection dates and helps facilitate any necessary arrangements (such as translation or travel coordination). This role is purely administrative – the agent is not conducting the inspection, but ensuring that FDA and the company can successfully schedule and carry out the inspection.
If the FDA is unable to contact the foreign establishment directly or quickly, it will send information or documents to the U.S. Agent. Providing documents to the U.S. Agent is legally considered equivalent to providing them to the foreign company. In other words, when the FDA delivers an official notice (such as an inspection finding, regulatory letter, or recall communication) to the U.S. Agent, the foreign manufacturer is deemed to have been notified. It is then the agent’s duty to forward those documents immediately to the company. This responsibility is critical in urgent situations – the U.S. Agent must be vigilant in checking for FDA communications and passing them on without delay.
It’s important to emphasize that the U.S. Agent’s duties are limited to the above areas. The agent serves as an FDA liaison, but is not responsible for the foreign manufacturer’s broader compliance obligations. For example, a U.S. Agent is not required to submit adverse event reports under Medical Device Reporting regulations or to file premarket submissions like 510(k) notifications on behalf of the company. Those responsibilities remain with the manufacturer (or with other designated entities such as the device’s importer or regulatory consultants). The U.S. Agent also does not implement corrective actions or quality changes at the foreign facility – the agent’s role is strictly to relay information and facilitate communication.
Because of this defined scope, foreign companies should not overestimate the U.S. Agent’s function. The agent’s effectiveness lies in promptly and accurately conveying information. If a U.S. Agent fails to forward a warning or delays a response to FDA, the foreign manufacturer will bear the consequences as if it had failed to respond itself. Thus, while the U.S. Agent’s tasks are few, they are vital for maintaining a smooth relationship with FDA. In the next section, we will discuss how to select a qualified U.S. Agent who can capably fulfill these duties.
