U.S. Agent Requirements for Foreign Medical Device Manufacturers: A Plain-English Guide
- 12 minutes ago
- 5 min read
By David Petrich, Landrich Group Co-Founder and VP of Quality and Regulatory
What Is a U.S. Agent?
As the world’s largest market for IVD devices, the United States has long been an attractive destination for manufacturers based in Europe, China, Japan, Korea, India, and other centers of medtech innovation.
A key factor in successful market entry is obtaining a U.S. Agent. This should not be conflated with a commercial role such as a distributor. A U.S. Agent serves as the FDA’s primary point of contact for a foreign medical device and diagnostics maker entering the U.S. market. The FDA will communicate with a foreign manufacturer through its U.S. Agent on common topics such as submission, registration, labeling, and scheduling foreign inspections.
This is separate from customs requirements. The nightmare scenario for any device maker is to reach the customs broker stage and learn their product cannot be shipped due to FDA registration problems.
Is a U.S. Agent Legally Required?
The legal requirement for a U.S. Agent is cited in 21 CFR Part 807.40. This applies to In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) manufacturers outside the United States selling into the U.S. market. It includes common actions such as submitting a 510(k), operating under an existing clearance, and even something as straightforward as registering with the FDA as a device manufacturer and listing medical devices.
The need to have a U.S. Agent is an ongoing obligation for any products marketed in the United States, not a one-time filing requirement. It's an ongoing obligation for as long as your device is marketed in the U.S.
The consequences for lacking a U.S. Agent designation are significant since this is prohibited under the Federal Food, Drug, and Cosmetic Act. If the FDA finds that a foreign firm has not maintained a U.S. agent, the agency may:
Refuse to accept your establishment registration or device listing.
Refuse to accept or process your premarket submission (510(k), PMA, De Novo).
Detain your device at the U.S. border by Customs if your registration is not current
List your firm as non-compliant, which can affect your U.S. distributors and customers
Who Can Serve as a U.S. Agent?
The FDA doesn’t require formal education, licensing, or certifications to become a U.S. Agent. Legally, the individual or firm does need to be physically located in the United States. They cannot use a P.O. Box as their address. They must be available to the FDA during normal business hours. When choosing a U.S. Agent, be wary of anyone who claims they have “FDA Accreditation” since the FDA does not accredit or certify.
Typically, U.S. Agents have vast expertise in regulatory affairs and have spent years studying the FDA medical regulations, like 21 CFR Part 820, as well as international standards like ISO 13485. U.S. Agents also often have Quality Assurance Engineer backgrounds, including a working knowledge of risk-based quality management, Quality-by-Design, ICH E6 (R3), and QMSR.
Can my US Distributor be my Agent?
There is nothing specifically disqualifying a U.S. Distributor from serving as a U.S. Agent. The key question is whether they have the regulatory expertise necessary to effectively communicate on your behalf with the FDA. Your U.S. Agent should have expertise handling FDA correspondence, responding to deficiency letters, and accurately conveying specifics of your submission and quality control systems. Make sure you ask any potential agent for specific examples of their experience and competency in this domain.
Your U.S. distributor can serve as your U.S. Agent. However, this is worth considering since distributors primarily have commercial expertise. A U.S. Agent should have regulatory expertise, with experience handling FDA correspondence, responding to deficiency letters, and communicating accurately about your submission and quality control systems.
A regulatory consulting firm experienced in device and IVD regulatory affairs is often better positioned to serve as U.S. Agent, because regulatory communication is its core function, not a secondary responsibility.
What the U.S. Agent Actually Does
Day-to-day, the U.S. Agent's responsibilities include:
Receiving and forwarding FDA correspondence to the foreign manufacturer
Responding to FDA requests for information on behalf of the manufacturer (within the scope of what the manufacturer has authorized)
Assisting the FDA with scheduling and conducting inspections of the foreign establishment
Maintaining current contact information with the FDA.
One thing a U.S. Agent is not responsible for is your device’s compliance with FDA requirements. This accountability remains solely with you as the manufacturer. This is important to understand, since it is unique and has a narrower scope than comparable agency relationships in other markets like Europe, Japan, and China. In other world markets, the local representative has broader responsibility and liability regarding your product’s entry into the market.
It is important to understand that the FDA views a U.S. Agent only as an information conduit. Their role is to help ensure the best possible interactions and coordination with the FDA based on regulatory insight.
How to Register Your U.S. Agent with the FDA
U.S. Agent information is registered through the FDA's Unified Registration and Listing System (FURLS). The registration must include the U.S. Agent's name, address, phone number, and email address. This registration must be updated annually and whenever the U.S. Agent changes.
In the past, foreign manufacturers have changed U.S. Agents while neglecting to update the FDA registration record. When this happens, the risk is that the FDA will send correspondence to an outdated U.S. Agent address and the current U.S. Agent doesn't receive it. The clock on the FDA's response timeline may continue to run regardless.
How to Choose a U.S. Agent
Earlier, we talked about the importance of vetting a potential U.S. Agent for regulatory domain expertise and watching for red flags. Here are some additional questions to ask:
Does the agent have specific experience with FDA communications for IVDs or medical devices (not just general business services)?
Can they receive, understand, and appropriately route FDA correspondence? This includes deficiency letters that require substantive regulatory knowledge to interpret? They should provide examples of how they have done this in the past.
Are they available during U.S. business hours and responsive within the timeframes FDA expects?
If the FDA schedules an inspection of your foreign establishment, can they help you prepare? Again, are specific examples critical?
You can ask them specific questions about key regulatory and quality trends in the US market to test their familiarity. For instance, how has the FDA's update to QMSR regulation impacted submission requirements? What is the recent trend regarding BIMO inspections? What is the FDA’s stance on Artificial Intelligence (AI) and Real Wold Evidence (RWE)?
For foreign manufacturers who are actively navigating the FDA for a complex submission, it often makes sense to have your clinical resource management partner act as the U.S. Agent so they can consult on broader strategy and implementation. This ensures you have a seasoned partner who is deeply familiar with all aspects of your product development goals in the US market.
David is a Quality and Regulatory executive with over 25 years of successful experience leading cross-functional teams to develop, manufacture, and commercialize In Vitro Diagnostics (IVD) and medical device products. He has a Bachelor of Science degree in Nutrition, an Executive MBA, and a Regulatory Affairs Certification (RAC). He is also a Certified Lead Auditor for ISO Standard 13485.
