The Role of a US Agent
Foreign manufacturers of medical devices and in vitro diagnostics (IVDs) that intend to market their products in the United States must retain a US Agent throughout the device life cycle. The US Agent serves as the primary point of contact between the FDA and the manufacturer. This requirement applies to all non-US manufacturers, regardless of device classification or submission type (510(k), De Novo, PMA, etc.). Without a US Agent, you cannot complete the FDA Establishment Registration process, which is required to legally market devices in the US.
Responsibilities of a US Agent for medical devices
An US Agent can be an individual or company, but they must be physically located in the United States. They cannot use a PO Box or answering service. The US Agent (or someone on their team) needs to be reachable by phone during standard US business hours. If the FDA can’t reach the foreign manufacturer directly or quickly enough, they may send important information or documents to the US Agent instead. In those cases, it’s treated the same as if the FDA had contacted the manufacturer directly.
Other US Agent responsibilities include:
- Assisting the FDA in scheduling inspections;
- Responding to questions related to the foreign establishment’s devices; and
- Accepting FDA communications and forwarding them to the manufacturer.
Unlike in-country representatives in other markets, the US Agent does not:
- Oversee Post-Market Surveillance or Medical Device Reporting for adverse events;
- Review or submit regulatory submissions (e.g., 510(k) submissions) for FDA review); or
- Appear on medical device labeling or IFU.
Without a confirmed US Agent, the FDA may be unable to deliver important communications, causing delays in inspections, regulatory actions, or responses to compliance issues. These gaps can result in noncompliance that could disrupt the distribution of your medical device.
How to choose the right a US Agent
US Agents are not required to maintain specific licenses or certifications. However, choosing the right US Agent can directly impact your compliance and communication with the FDA. Manufacturers should prioritize candidates with strong regulatory knowledge, a solid understanding of FDA procedures, and a track record of responsiveness. It’s also important to consider potential conflicts of interest; for example, while a US-based distributor may be eligible to serve as your US Agent, their business priorities may not always align with your regulatory needs. An independent, experienced regulatory partner can provide objective, timely support and ensure that no communication is missed.
How to appoint your US Agent
Foreign manufacturers must provide the US agent’s full contact details, including name, physical address, phone, fax, and email as part of the electronic Establishment Registration process using the FDA’s FURLS system. After the manufacturer submits the registration, the FDA sends an email to the US Agent asking them to confirm their agreement to act on the company’s behalf. The US Agent must respond through the FDA’s automated system. If they decline or fail to respond within 10 business days, you must assign a new US Agent to remain in compliance.
What’s the difference between a US Agent and an Official Correspondent?
The US Agent and Official Correspondent play important roles in FDA compliance but serve distinct functions:
An US Agent is required only for companies located outside the United States and serves as the FDA’s primary point of contact for the foreign establishment.
An Official Correspondent is required for both foreign and domestic establishments and is responsible for managing the company’s registration and device listing information through the FDA’s Unified Registration and Listing System (FURLS). This role involves maintaining the FURLS account, handling annual registration renewals, and receiving correspondence from the FDA related to establishment registration and product listings. The Official Correspondent can be based in the US or abroad and may be an employee of the manufacturer or a designated third party.
The same person or organization can serve as the US Agent and the Official Correspondent if the distinct responsibilities and requirements of each role are fulfilled.
