FDA regulations impose legal duties on both foreign manufacturers and their U.S. Agents. From appointing and updating agents to ensuring consent, availability, and accurate communication, meeting these obligations is key to U.S. market compliance.
FDA regulations impose clear legal obligations on both the foreign device manufacturer and the designated U.S. Agent. Compliance with these requirements is not optional – it is mandated by law, and failure to adhere can result in regulatory violations. Below is an overview of the key legal obligations:
Every foreign establishment that must register with FDA is required to appoint one U.S. Agent and submit the agent’s name, address, and phone number as part of its establishment registration. This must be done at the initial registration and whenever the information changes. The agent must have a physical presence in the U.S. (as noted, a physical address is required – no P.O. boxes or virtual offices).
By law, the U.S. Agent must reside in the United States or maintain a place of business there. It is the foreign manufacturer’s responsibility to choose an agent that fulfills this criterion. If an appointed agent no longer meets this criterion (for example, they relocate outside the U.S.), the manufacturer must replace them promptly to remain in compliance.
The foreign establishment (or the agent itself) is legally required to notify FDA of any changes to the U.S. Agent’s identity or contact information within 10 business days. This includes if you change your U.S. Agent or if the agent’s address or phone number changes. Practically, this is done by updating the establishment’s registration profile in FDA’s FURLS system. A foreign manufacturer should not allow a gap in coverage – there must always be one current U.S. Agent on file. If your agent resigns or you end the relationship, you must designate a new agent and update the FDA promptly.
FDA requires device establishments to renew their registration (and pay the annual user fee) every year. As part of this process, the U.S. Agent information must be verified or updated. Failure to complete the annual renewal or pay the fee will result in the registration lapsing. An expired registration means the foreign company no longer has a valid U.S. Agent on record and cannot legally import devices until the registration is reinstated.
When a foreign manufacturer lists someone as its U.S. Agent, that agent is expected to formally consent to the role (as discussed, FDA’s system sends a verification request that the agent must confirm). By agreeing to serve, the U.S. Agent undertakes the responsibility to perform the tasks set out in regulation. By regulation, the U.S. Agent shall assist in communications, answer FDA’s questions, and help schedule inspections upon FDA’s request. This is the agent’s legal duty as FDA liaison. If an agent cannot or will not carry out these duties, they should not accept the appointment.
The agent is obligated to remain available to FDA during typical business hours. Although not explicitly a “penalty” in the regulation, failing to be reachable defeats the purpose of the role and can lead FDA to deem the foreign company out of compliance. The agent should ensure that FDA has current contact information at all times. If the agent’s contact info changes (phone number, address, etc.), the agent shares in the responsibility to report that update to FDA within 10 days. This dual reporting provision (by either the agent or the foreign firm) is intended to prevent situations where an agent’s contact becomes outdated without FDA’s knowledge.
It is important to note that legally, the U.S. Agent’s responsibilities are limited to those liaison functions described in the regulation. The agent is not personally responsible for the manufacturer’s compliance with product requirements, quality system regulations, or other regulatory filings. For example, if a device must be recalled or if a 510(k) application must be submitted, those remain the manufacturer’s duties (or those of another authorized representative like an initial importer for certain post-market reporting). The U.S. Agent’s legal obligation is to facilitate communication, not to assume the manufacturer’s regulatory burdens.
Failure to comply with these requirements can have serious consequences. A foreign manufacturer that does not maintain a U.S. Agent in accordance with FDA rules is considered out of compliance. FDA can refuse imports of devices from such a company and may take enforcement action. Likewise, if an agent consistently fails to perform their duties and FDA cannot reach the company, the risk of warnings or other sanctions increases.
By understanding and adhering to the legal requirements – designating a qualified U.S. Agent, keeping the agent information current, and ensuring the agent fulfills their duties – foreign manufacturers can avoid regulatory pitfalls. These obligations form the foundation of a compliant U.S. market entry. In the next section, we will discuss how the U.S. Agent interacts with FDA during inspections and other compliance activities (and how companies can leverage this role to their advantage).
