Entering the U.S. medical device market can be a major opportunity for international companies. However, to operate legally and safely, companies must meet FDA requirements. One of them is appointing a US Agent for FDA registration.
But what exactly does this agent do, and why is it so important?
Below, understand the role of the US agent for FDA registration. Learn how it can directly impact a product’s entry into — and continued presence in — the American market.
What is a US agent for FDA registration?
Foreign companies marketing medical devices in the United States must understand what a US agent for FDA registration is.
At first glance, the term may seem technical. However, its role is quite straightforward and extremely important within the regulatory framework of the Food and Drug Administration (FDA).
A US agent for FDA registration is an individual or legal entity located in the United States. Appointed by a foreign company, this agent acts as the official point of contact and liaison with the FDA.
This designation is mandatory for any company based outside the United States that intends to register products with the FDA. It includes medical devices.
The primary function of a US agent for FDA registration is to serve as a communication channel between the agency and the foreign company.
In sensitive or urgent regulatory situations, the FDA may not reach the foreign company quickly or directly. When it happens, the U.S. agent becomes the official point of contact.
In practice, the agent receives notifications, requests for information, regulatory updates, and even inspection scheduling communications.
Responsibilities
In addition to acting as an intermediary, the US agent for FDA registration may also have specific responsibilities, such as:
- Assisting with the registration process and the ongoing maintenance of the foreign company’s information in the FDA database;
- Responding to letters or requests issued by the agency, especially when response timelines are short;
- Acting as the official point for receiving and forwarding FDA communications related to any corrective actions required from the manufacturer.
It is important to note that a US agent for FDA registration does not need to be an attorney. What matters most is that the agent responds promptly to FDA communications and understands regulatory processes well.
The designation of the US agent for FDA registration is made at the time of the foreign establishment’s registration with the FDA. This designation must be updated annually during the period known as the Establishment Registration Renewal. The company is responsible for ensuring that the agent remains active and willing to perform their duties.
Therefore, the US agent for FDA registration is a regulatory requirement that goes beyond a mere formality. It is a strategic partner that ensures the company remains visible, accessible, and compliant with U.S. regulatory rules.
When does a company need a US agent for FDA registration?
According to 21 CFR Part 807, any foreign company that manufactures, packages, or distributes medical devices for the United States must designate a US Agent for FDA registration at the time of Establishment Registration.
This designation is made through the FURLS system (FDA Unified Registration and Listing System) and must be renewed annually.
The US Agent is an individual or legal entity located in the United States, appointed by the foreign company to act as the official point of contact with the FDA. This role is mandatory for:
- Establishment Registration;
- Medical Device Listing;
- Annual registration renewal;
- Communication during inspections or regulatory actions.
This requirement also applies to companies that manufacture and wish to export directly to the United States; outsource manufacturing and intend to register products under their own name; or operate as a global distributor and plan to sell devices in the country under their own brand.
Attention: the FDA does not allow the foreign company itself to act as its own agent.
The agent must be a legally established entity in the United States, with a physical address and accessible contact information.
In other words, if a company operates only in Brazil, for example, without a presence in the United States, and wishes to register its medical devices, it must appoint a US agent for FDA registration.
Responsibilities of the US agent for FDA registration in the regulatory process
Although the role of the US agent for FDA registration may seem merely formal, in practice it carries important responsibilities that directly influence a company’s regulatory success.
The agent is not just a “symbolic representative,” but a formally designated party responsible for acting as the official communication channel with the FDA on behalf of the company.
Below are the main responsibilities of the US agent for FDA registration in the context of medical devices:
1. Official communication with the FDA
The most relevant function of the agent is to act as the foreign company’s official point of contact with the FDA.
In practice, this includes receiving correspondence, notifications, and notices from the FDA, as well as promptly forwarding these communications to the company.
The agent also assists in understanding regulatory requests and deadlines.
Keep in mind that many FDA requirements have short response timelines. For this reason, efficient communication between the FDA and the agent is essential.
2. Support for Establishment Registration and Device Listing
During the Establishment Registration and Device Listing processes with the FDA, the US Agent may provide operational support.
This means assisting with the completion of electronic forms in the FURLS system, based on the information provided by the manufacturer.
The agent also acts as the point of contact for the inclusion and maintenance of establishment data and listed devices.
In addition, the agent provides support for updates required during the annual renewal period.
Keep in mind that the US agent for FDA registration is not the legal or technical party responsible for the product’s regulatory content. Their role is to act as the official representative and communication channel between the foreign manufacturer and the FDA.
3. Support during FDA inspections and import-related communications
In cases of FDA inspections or questions related to the importation of medical devices, the US Agent may act on different communication fronts.
This includes, for example, receiving and forwarding FDA notifications, as well as supporting the coordination of contacts between the agency and the manufacturer during the inspection process.
The agent may also act as a communication channel for requests related to importation processes, when applicable.
4. Communication and support during regulatory actions
If a product or establishment is subject to regulatory actions (such as the issuance of a Warning Letter, Import Alert, or notifications related to a recall), the agent acts as the FDA’s official point of contact — especially when the agency is unable to communicate directly with the manufacturer.
In this context, the agent may receive and immediately forward regulatory notifications to the manufacturer, ensuring that FDA communications are conveyed accurately and in full.
In addition, the agent may help align communications between the FDA and the company during the initial stages of the response.
However, it is important to note that the US agent for FDA registration does not assume technical or legal responsibility for the product. The agent also does not prepare regulatory responses, action plans, or technical strategies.
Their role is limited to regulatory communication and support in fulfilling the formal steps required by the FDA.
Even so, the speed, organization, and clarity of the US Agent’s actions can directly influence the flow of communication and the progress of regulatory interactions.
Criteria for choosing a US agent for FDA registration
Designating a US Agent is an FDA regulatory requirement, but choosing who will fulfill this role is a strategic decision.
A poorly prepared agent can delay processes, create communication issues with the agency, and even jeopardize a product’s entry into the U.S. market.
For this reason, it is essential to know what to consider when hiring or appointing a US agent for FDA registration.
Below are the main criteria for choosing a reliable and effective agent:
- Location and presence in the United States: The agent must have a physical residence or headquarters in the United States.
- Ability to communicate quickly and clearly: One of the main roles of the US Agent is to receive and relay FDA communications in a timely manner. Therefore, the agent must be fluent in English, have active communication channels, and be readily available to respond promptly.
- Knowledge of FDA regulations: It is highly recommended that the agent have a basic understanding of FDA processes. An experienced agent can anticipate potential issues and properly guide the company from the outset.
- Confidentiality and accountability: The US agent for FDA registration will have access to sensitive company information, such as registration data and potential corrective actions. For this reason, the agent must demonstrate professionalism and ethical conduct, in a relationship based on mutual trust and a commitment to compliance.
At Sobel, all of these criteria are met with efficiency.
With a team of regulatory specialists, we act as a US agent for FDA registration, ensuring formal communication between the foreign manufacturer and the FDA, within the scope established by the regulations.
By choosing Sobel as your US agent for FDA registration, you gain greater peace of mind when entering the U.S. market, knowing that all legal requirements are being met.
Would you like to learn more about our role as a US agent for FDA registration? Send us a message and speak with a consultant specialized in the subject.
What happens if you do not designate a US agent for FDA registration?
As you know, designating a US agent for FDA registration is a mandatory requirement.
Foreign companies that wish to register medical devices in the United States cannot ignore this rule.
This is because there are significant risks associated with the absence of — or improper designation of — a US Agent.
To begin with, without a designated US Agent, a company cannot complete its Establishment Registration or Device Listing. This prevents any progress in regulatory processes.
If a company that is already registered fails to renew or update its US Agent on an annual basis, the FDA may suspend the establishment’s status in the FURLS system and may even invalidate the product’s registration number.
In addition, if the FDA attempts to contact the company and does not receive a response through the US Agent, this may be interpreted as regulatory noncompliance. A lack of response can result in penalties, import alerts, and even a prohibition on entering the country.
Finally, beyond financial losses, errors related to the designation of the FDA US Agent can harm the company’s reputation in the U.S. market. Distributors, hospitals, and buyers require assurance that products are properly registered and compliant with FDA requirements.
An agent with an essential role
Entering the U.S. medical device market can be an excellent opportunity for international growth, but it requires careful attention to FDA regulatory requirements.
Having an FDA US Agent is essential for foreign companies to register their products and communicate effectively with the regulatory authority.
Therefore, when planning your regulatory strategy, be sure to rely on a qualified US agent for FDA registration.
Sobel can support you in this and in other aspects of the U.S. regulatory process. Having the right support can make all the difference between a smooth and successful market entry.
If your company is planning to export medical devices to the United States, start on the right foot: understand the requirements, organize your documentation, and rely on a trusted FDA US Agent from the very beginning of the process.
In this way, you ensure not only legal compliance, but also a solid foundation to expand your international presence with confidence and professionalism.
