Foreign manufacturers must actively maintain U.S. Agent status by updating contact details, managing agent changes, and avoiding representation gaps to ensure FDA compliance, smooth communication, and uninterrupted imports.
Designating a U.S. Agent is not a one-and-done task. Circumstances can change over time, and it’s crucial for foreign manufacturers to actively maintain their U.S. Agent status. FDA regulations require prompt updates whenever there are changes to the U.S. Agent’s information or representation. Here’s how to properly manage updates and agent changes to stay compliant:
If your U.S. Agent’s contact details (such as phone number, email, or office address) change, you must update this information with the FDA within 10 business days. Even seemingly minor changes – like a new suite number for the agent’s office – should be updated to ensure FDA can reach the agent. The FDA’s FURLS online system allows manufacturers (or their official correspondent) to edit the U.S. Agent contact info in the establishment registration profile at any time. It’s wise to confirm the agent’s details during your annual registration renewal as well, but do not wait for the annual cycle if something changes mid-year. Keeping the agent’s contact information current is a straightforward obligation, yet it’s essential for uninterrupted communication.
There are many reasons a company might need or choose to change its U.S. Agent. Perhaps the business relationship with the current agent has ended, the agent is not as responsive as expected, or the company has decided to appoint a different agent (for example, after opening a U.S. office or switching to a specialized service provider). To change the agent on record, the foreign manufacturer must update the FDA registration with the new agent’s information and also inform the old agent of the change. When you designate a new agent in FURLS, the FDA will send an automated email to that person or firm asking them to confirm their agreement to serve. It is important to ensure the new agent is expecting this verification request. If the new agent does not respond within 10 days or declines, the change will not go through and FDA will continue to consider the previous agent as the official contact. Only one U.S. Agent can be active at a time, so by adding a new agent, you are effectively removing the previous one.
From a compliance standpoint, you should strive to have zero downtime between agents. Ideally, coordinate the timing so that the new agent’s appointment overlaps or immediately succeeds the former agent’s term. For instance, if you know your current agent will cease acting as of a certain date, initiate the change process in advance so the new agent confirms and becomes effective by that date. Remember that if at any point you have no U.S. Agent on file, you are out of compliance and your device imports could be halted. FDA does not provide any grace period beyond the 10-business-day update window. If an agent unexpectedly resigns or cannot continue (e.g., a consulting firm stops offering the service), treat the situation as urgent – find a replacement and update FDA as soon as possible.
Whenever a U.S. Agent change is made, document the change in your internal records (noting the effective date of the new agent). It’s also a good practice to notify any relevant business partners or distributors in the U.S. about the new agent, so they know who to contact in regulatory matters. While FDA will update its internal systems once you file the change, if any FDA correspondence was recently sent to the old agent, ensure the old agent forwards it or the FDA resends it to the new agent. During the transition, you may want the old agent to remain available for any pending communications until FDA’s database reflects the update.
In some cases, the U.S. Agent may initiate the termination (for example, a consultant might decide to discontinue acting as an agent for certain clients). The agent can inform FDA of their withdrawal, but the onus is ultimately on the foreign manufacturer to immediately appoint a new agent. A conscientious agent who plans to resign should ideally give advance notice to the manufacturer to avoid a compliance gap. Nonetheless, manufacturers should monitor their FDA registration status; if an agent ever withdraws and you receive notice, act quickly to assign a new agent.
Maintaining your U.S. Agent is an ongoing responsibility that parallels other regulatory upkeep like license renewals or quality system updates. By promptly updating contact information and smoothly handling any agent transitions, you ensure that your lines of communication with FDA remain open. This vigilance prevents unwanted surprises – such as missed notices or import delays – and reinforces to FDA that your company is diligent about its U.S. regulatory obligations.
