Quick Answer
A US Agent is a person or business located in the United States that every foreign facility must designate before registering with FDA. The US Agent serves as the official communication link between FDA and the foreign facility for all regulatory matters including inspections, recalls, and emergency notifications. This requirement applies to all FDA-regulated product categories: food, drugs, medical devices, and cosmetics.
Regulatory Authority: 21 CFR Part 1, Subpart H — Registration of Food Facilities, Section 1.227. Additional authority: 21 CFR 207.69 (drugs), 21 CFR 807.40 (devices), FD&C Act Section 612 (cosmetics under MoCRA).
What Is an FDA US Agent?
An FDA US Agent is a person or company physically located in the United States that is designated by a foreign facility to act as the facility's point of contact with FDA. Under federal regulation, every foreign establishment that manufactures, processes, packs, or holds FDA-regulated products intended for US consumption must have a US Agent in place before completing their FDA registration.
The US Agent requirement was established by the Bioterrorism Act of 2002 for food facilities and has since been extended to drug establishments (21 CFR 207.69), medical device establishments (21 CFR 807.40), and cosmetics facilities under the Modernization of Cosmetics Regulation Act (MoCRA). The purpose is to ensure FDA always has a reliable, US-based point of contact for foreign facilities, particularly during emergencies such as product recalls, foodborne illness outbreaks, or safety alerts.
The US Agent does not take ownership of products, does not serve as the importer of record, and is not responsible for customs clearance. Their role is strictly regulatory — receiving, responding to, and forwarding FDA communications on behalf of the foreign facility. For a broader overview of agent requirements, see our US Agent Requirements Guide.
Who Needs a US Agent?
Any facility located outside the United States that exports FDA-regulated products to the US market must designate a US Agent. This applies to the following product categories:
Food Facilities
Foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US. Governed by 21 CFR Part 1, Subpart H and FSMA requirements.
Food registration detailsDrug Establishments
Foreign drug establishments that manufacture, repack, relabel, or salvage drugs for US distribution. Governed by 21 CFR Part 207 and the FD&C Act.
Medical Device Establishments
Foreign medical device establishments that manufacture, prepare, propagate, compound, assemble, or process devices for US distribution. Governed by 21 CFR Part 807.
Cosmetics Facilities (MoCRA)
Foreign cosmetics facilities that manufacture or process cosmetic products for US distribution. Required under MoCRA effective December 2023.
MoCRA compliance guideTobacco product facilities also require a US Agent but are covered under separate FDA tobacco regulations. If your facility falls into any of the categories above and is located outside the US, you are legally required to have a US Agent before completing registration. Use our US Agent Wizard to determine exactly what you need.
Legal Requirements and Responsibilities (21 CFR 1.227)
The US Agent's responsibilities are defined in federal regulation. Under 21 CFR 1.227 (for food facilities), the US Agent must fulfill the following obligations. Parallel requirements exist under 21 CFR 207.69 for drugs and 21 CFR 807.40 for devices.
Core Responsibilities
Critical Legal Point
When FDA delivers a warning letter, import alert, or other regulatory action to a US Agent, it is legally considered delivered to the foreign facility. The foreign facility cannot later claim it did not receive notice. This makes choosing a responsive, reliable US Agent essential for protecting your business.
What a US Agent Is NOT
It is important to understand the limitations of the US Agent role to avoid confusion with other positions in the supply chain:
- Not an Importer of Record: The US Agent does not handle customs entries, duties, or import paperwork
- Not an FSVP Importer: The US Agent is not responsible for Foreign Supplier Verification activities
- Not a Product Distributor: The US Agent does not take physical possession of products or manage distribution
- Not Liable for Product Quality: The US Agent is not responsible for the safety or quality of the foreign facility's products
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Assurentry provides same-day US Agent designation with a compliance dashboard and 24/7 support.
Start My RegistrationHow to Select the Right US Agent
Choosing the right US Agent is a critical decision that directly affects your ability to maintain FDA compliance and keep your products flowing into the US market. Consider the following factors when evaluating US Agent providers:
Key Selection Criteria
- Regulatory Expertise: Does the agent understand FDA regulations specific to your product category (food, drugs, devices, cosmetics)? A generic agent may miss category-specific requirements.
- Response Time: How quickly does the agent respond to FDA inquiries? Delays can result in escalated enforcement actions or detained shipments.
- Technology and Transparency: Does the agent provide a dashboard or portal where you can track communications, registration status, and renewal deadlines?
- Language Support: Can the agent communicate effectively with your facility in your native language?
- Renewal Management: Will the agent proactively remind you about biennial registration renewals and annual listing updates?
- Business Stability: How long has the agent been in operation? A provider that closes unexpectedly leaves your facility without an agent, risking import refusal.
US Agent Options
| Option | Pros | Cons |
|---|---|---|
| Professional US Agent Service | Dedicated focus, regulatory expertise, reliable availability, compliance tools | Annual service fee ($250-$900/yr) |
| US Importer / Distributor | No additional cost, existing business relationship | May lack regulatory expertise, tied to business relationship |
| US Subsidiary Employee | Internal resource, no external fees | Employee turnover risk, may lack FDA knowledge |
| Regulatory Attorney / Consultant | Deep regulatory expertise, legal advice | Higher cost ($1,000-$5,000+/yr), may be over-scoped |
US Agent Cost Comparison (2026)
US Agent pricing varies significantly based on the provider and what services are bundled with the agent designation. Below is a comparison of commonly used US Agent service providers for 2026:
| Provider | Annual Cost | Services Included |
|---|---|---|
| Assurentry | $399/year | US Agent + Compliance Dashboard + Renewal Reminders + 24/7 Support |
| Registrar Corp | Contact for Quote | US Agent + Basic Support |
| FDA Solutions Group | $300-500/year | US Agent + Basic Registration |
| FDABasics | $250-299/year | US Agent Only |
| Willow Glen | $279/year | US Agent Only |
When evaluating cost, consider the total value of what is included. Bare-bones US Agent services at a lower price may lack renewal tracking, compliance dashboards, or responsive support — all of which can cost you significantly more if a regulatory issue arises. For a detailed comparison, visit our Assurentry vs. Registrar Corp page.
Country-Specific Requirements
While the FDA US Agent requirement is the same regardless of where your facility is located, certain countries have unique considerations related to export compliance, language barriers, and documentation requirements. Here is country-specific guidance for the top exporting nations:
China
China is the largest source of FDA-regulated imports. Facilities must comply with GACC Decree 248 for food exports in addition to FDA registration. Mandarin-language support from your US Agent is critical. Prior notice filing is required for every food shipment.
China export guideIndia
India is a major exporter of generic pharmaceuticals, spices, and dietary supplements. Drug establishments must comply with 21 CFR Part 207 registration and listing. FSVP requirements apply to food imports from India.
India export guideMexico
Mexico benefits from USMCA trade provisions but still requires full FDA registration and US Agent designation. High volume of fresh produce imports triggers additional FSMA Produce Safety Rule requirements.
Mexico export guideGermany
Germany is a leading exporter of medical devices, pharmaceutical ingredients, and specialty food products. EU CE marking does not satisfy FDA requirements — separate US registration and US Agent are required.
Japan
Japan exports significant volumes of medical devices, cosmetics, and processed foods to the US. PMDA-approved products still require separate FDA registration. Japanese-language support from your US Agent is recommended.
South Korea
South Korea is a major exporter of cosmetics (K-beauty), electronics-related devices, and food products. MoCRA registration is now required for all cosmetic facilities exporting to the US.
Korea export guideBrazil
Brazil exports large volumes of food products (coffee, orange juice, poultry) to the US. ANVISA approval in Brazil does not replace FDA registration. Portuguese-language support can streamline communications.
Brazil export guideItaly
Italy is a top exporter of specialty foods (olive oil, cheese, pasta), wine, and cosmetics. EU food safety certifications do not satisfy FDA requirements. Facilities must obtain a separate FDA registration with a US Agent.
Regardless of your country, the core US Agent requirement remains the same. For a comprehensive guide to importing into the US, see our FDA Import Compliance Guide.
How to Change Your US Agent
You may need to change your US Agent for several reasons: your current agent is unresponsive, you want better compliance support, your business relationship has ended, or you found a more cost-effective option. The process is straightforward:
Step-by-Step Process
- Select your new US Agent: Confirm the new agent agrees to the designation and provides an acceptance letter with their US address, phone number, and email address.
- Log in to FDA's registration system: Access the appropriate FDA registration portal for your product type (FURLS for food, DRLS for drugs, CDRH for devices).
- Update US Agent information: Navigate to your facility registration and update the US Agent fields with the new agent's contact information.
- Submit the update: The change takes effect immediately upon successful submission. FDA does not charge a fee for this update.
- Confirm with your new agent: Verify that your new US Agent has received the registration confirmation and is ready to act on your behalf.
Important Timing Note
Federal regulations require that you update your US Agent information within 60 days of any change. Do not leave a gap in US Agent coverage — if FDA attempts to contact your facility through an outdated or non-functional US Agent, it can trigger enforcement action including import refusal and registration cancellation.
Common US Agent Mistakes to Avoid
Foreign facilities often make avoidable errors when designating or managing their US Agent. These mistakes can result in registration delays, import refusals, or FDA enforcement actions.
Mistake #1: Using a P.O. Box as the US Agent Address
FDA requires the US Agent to have a physical US street address. A P.O. box is not acceptable. If your US Agent provides only a P.O. box, your registration may be rejected or flagged for review.
Mistake #2: Not Updating After a US Agent Change
If your US Agent resigns or your business relationship ends, you must update your FDA registration immediately. A lapse in US Agent coverage means FDA cannot contact your facility, which can result in shipment detentions at US ports.
Mistake #3: Confusing US Agent with FSVP Importer
The US Agent and FSVP importer are separate roles with different legal obligations. Having a US Agent does not satisfy FSVP requirements, and your FSVP importer is not automatically your US Agent unless specifically designated.
Mistake #4: Choosing the Cheapest Agent Without Vetting
The lowest-cost US Agent may not respond to FDA promptly, may lack regulatory expertise, or may go out of business. An unresponsive US Agent is worse than an expensive one — it can cost you your ability to export to the US entirely.
Mistake #5: Forgetting Biennial Registration Renewal
Food facility registrations must be renewed during the biennial renewal period (October 1 through December 31 of even-numbered years). If you miss the renewal window, your registration becomes inactive and your products can be refused at the border. A good US Agent will remind you of this deadline.
Assurentry US Agent Services
Assurentry provides dedicated US Agent services for foreign facilities across all FDA-regulated product categories. Our service is designed to give foreign facilities reliable FDA compliance support at a transparent, flat-rate price.
What Is Included
Assurentry's US Agent service is priced at $399/year with no hidden fees. Visit our US Agent service page to get started or learn more about how we can support your facility.
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Designate US Agent — $399/yrFrequently Asked Questions
What is a US Agent for foreign facilities?
A US Agent is a person or company located in the United States that serves as the official communication link between a foreign facility and FDA. Under 21 CFR 1.227, every foreign facility that manufactures, processes, packs, or holds FDA-regulated products for US export must designate a US Agent before completing their FDA registration.
How much does a US Agent cost per year?
US Agent costs typically range from $250 to $900 per year depending on the provider and level of service. Assurentry charges $399/year and includes a compliance dashboard, renewal reminders, and 24/7 support. Some providers charge additional fees for registration assistance or document handling.
Can a foreign facility owner serve as their own US Agent?
No. The US Agent must be a person or business physically located in the United States that is separate from the foreign facility. Even if the facility owner has a US mailing address or travel visa, they cannot serve as their own US Agent unless they reside or maintain a place of business in the US per 21 CFR 1.227.
What happens if a foreign facility does not have a US Agent?
A foreign facility cannot complete its FDA registration without designating a US Agent. Without valid registration, all products from that facility will be refused entry at US ports. FDA may also place the facility on import alert, which subjects all future shipments to automatic detention.
How do I change my US Agent with FDA?
You can change your US Agent at any time by logging into the FDA registration system and updating your US Agent information. The change takes effect immediately upon successful submission. You should update within 60 days of any change in your US Agent arrangement to remain compliant.
Does FDA charge a fee for designating a US Agent?
No. FDA does not charge a fee specifically for designating a US Agent. The US Agent designation is part of the facility registration process. However, the US Agent service provider (such as Assurentry) charges their own annual service fee for acting in this role.
Can one US Agent represent multiple foreign facilities?
Yes. A single US Agent can represent an unlimited number of foreign facilities. Professional US Agent services like Assurentry typically represent hundreds or thousands of facilities across food, drug, device, and cosmetics categories simultaneously.
Is the US Agent liable for the foreign facility's products?
No. The US Agent is not generally liable for product safety or regulatory compliance of the foreign facility's products. Their regulatory role is limited to serving as a communication link between FDA and the foreign facility. However, they can be held liable for their own misrepresentations or actions.
Do I need a US Agent for cosmetic products under MoCRA?
Yes. Under the Modernization of Cosmetics Regulation Act (MoCRA), foreign facilities that manufacture or process cosmetic products for US distribution must now register with FDA and designate a US Agent, similar to the requirements for food, drugs, and devices.
How quickly can I get a US Agent assigned?
With Assurentry, US Agent acceptance letters are issued same-day upon completing the onboarding process. The acceptance letter can be used immediately to complete or update your FDA registration. Some providers may take several business days to process new designations.
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