The Complete Guide to FDA US Agent Services in 2026

What Is a US Agent?

A US Agent serves as the official point of contact between FDA and a foreign establishment. When FDA needs to reach a foreign facility whether for routine communications, inspection scheduling, or emergency situations like recalls the US Agent is the first call.

The requirement exists because of the practical challenges of communicating across time zones, languages, and international boundaries. FDA needs a reliable, US-based contact who can respond promptly and relay information to the foreign facility.

Who Needs a US Agent?

A US Agent is required for any foreign establishment that exports FDA-regulated products to the United States. This includes facilities in all major FDA-regulated categories:

• Food facilities: Foreign manufacturers, processors, packers, and holders of food for human or animal consumption (learn more)
• Drug establishments: Foreign manufacturers, repackers, relabelers, and drug salvagers (learn more)
• Medical device establishments: Foreign manufacturers and distributors of medical devices (learn more)
• Cosmetics facilities: Under MoCRA, foreign cosmetics facilities must now register and designate a US Agent (learn more)
• Tobacco product establishments: Foreign manufacturers of tobacco products for US import

Domestic US facilities do not need a US Agent. The requirement applies exclusively to establishments located outside the United States.

US Agent Responsibilities

A US Agent has specific responsibilities defined by FDA regulations. Understanding these is critical both for foreign facilities selecting an agent and for evaluating whether your current agent is performing adequately.

Core Duties

• Accept FDA communications: Receive warning letters, recall notices, inspection requests, and other official correspondence
• Respond to FDA inquiries: Provide timely answers to FDA questions and requests for information
• Forward communications: Promptly relay all FDA correspondence to the foreign facility
• Assist with regulatory processes: Help coordinate inspections, registrations, and other regulatory interactions

What a US Agent Does Not Do

It is important to understand the limitations. A US Agent does not automatically become your importer of record, assume FSVP responsibilities, or take on product liability. These are separate regulatory roles with their own requirements.

How Much Does a US Agent Cost?

US Agent service pricing varies significantly depending on the provider, the scope of services included, and the product category. Here is what you can expect:

For a detailed cost comparison, visit our US Agent cost breakdown page or see how Assurentry compares on our best US Agent services guide.

How to Choose the Right US Agent

Not all US Agent services are created equal. Here are the key factors to evaluate when choosing a provider:

Common Mistakes to Avoid

We see foreign facilities make the same US Agent mistakes repeatedly. Here are the most common pitfalls:

1. Using an unresponsive importer as US Agent: If your importer relationship ends, your US Agent designation disappears too. Professional services provide continuity.
2. Choosing the cheapest option: Budget providers that offer nothing beyond a name listing leave you exposed when FDA actually contacts your agent.
3. Not updating your registration: If you change US Agents, you must update your FDA registration within 60 days. Failure to do so can result in registration issues.
4. Ignoring renewal deadlines: Food facilities must renew registrations biennially. Your US Agent should proactively remind you of these deadlines.
5. No communication protocol: Establish clear procedures for how your US Agent will contact you, especially for urgent FDA communications.

Getting Started

Appointing or changing your US Agent is straightforward. Here is the process:

1. Choose a US Agent provider (we recommend evaluating at least 2-3 options)
2. Provide your facility and product information to the new agent
3. The US Agent confirms their role and provides their contact details
4. Update your FDA registration with the new US Agent information
5. Set up communication protocols and emergency contact procedures

The entire process typically takes 1-3 business days when working with a professional service. For more details, see our comprehensive US Agent requirements guide or visit our main US Agent services page.