21 CFR 807.40 U.S. Agent Requirements (Plain English)
Understand 21 CFR 807.40 U.S. Agent requirements for foreign device establishments. Plain English explanation of FDA regulations, compliance checklist, and how to choose compliant providers. Compare options and get quotes.
Plain-English Summary of 21 CFR 807.40
If you're reading 21 CFR 807.40, you're probably trying to figure out what FDA actually requires. Here's the plain-English version: every foreign medical device establishment must name someone in the United States as their U.S. Agent before FDA will complete their registration.
The regulation is short but specific. The agent must be physically located in the U.S. (or a U.S. territory like Puerto Rico). They need a real address—not a PO box. FDA explicitly prohibits PO boxes because they need someone who can actually receive mail during business hours.
Why does this exist? FDA needs a reliable way to reach foreign manufacturers. When FDA schedules an inspection, issues a recall, or needs to send regulatory correspondence, they send it to your U.S. Agent's address. The agent then forwards it to you. Without this system, FDA would struggle to communicate with foreign companies, especially during urgent situations.
Here's what trips people up: the regulation doesn't specify how quickly the agent must forward communications. It just says they must forward them. That's why response time SLAs vary so much between providers—some guarantee same-day forwarding, others might take 48 hours. The regulation sets the minimum requirement, but good providers exceed it significantly.
One critical detail: the agent must be available during business hours to receive FDA communications. This isn't just about having an address—someone needs to be there (or checking mail regularly) to ensure nothing sits unopened. Virtual mailboxes that aren't checked daily don't meet this requirement, even if they have a physical address.
Without a compliant U.S. Agent designation, your establishment registration simply won't complete in FURLS. The system requires this field, and FDA reviews it. If they find a PO box or invalid address, they'll reject your registration and you'll have to fix it, adding days or weeks to your timeline.
21 CFR 807.40 Text (Reference)
The full regulation states:
§ 807.40 U.S. Agent for foreign establishments.
(a) A foreign establishment must designate a U.S. agent for purposes of section 510(i) of the Federal Food, Drug, and Cosmetic Act.
(b) The U.S. agent must be located in the United States or in a territory of the United States.
(c) The U.S. agent must have a place of business in the United States or in a territory of the United States.
(d) The U.S. agent cannot be a post office box.
What Is Required vs Optional (Compliance Table)
Understanding what 21 CFR 807.40 requires versus what's optional helps you choose the right U.S. Agent provider:
| Requirement | Required | Optional | Notes |
|---|---|---|---|
| Physical U.S. Location | ✓ Yes | Agent must be physically located in U.S. or U.S. territory | |
| Valid U.S. Address | ✓ Yes | Must be a real address, not a PO box | |
| Business Hours Availability | ✓ Yes | Must be available to receive FDA communications | |
| Forwarding Communications | ✓ Yes | Must forward all FDA correspondence to foreign establishment | |
| Same-Day Forwarding | ✓ Optional | Not required by regulation, but many providers offer this | |
| Inspection Support | ✓ Optional | Not required, but helpful for coordination | |
| Official Correspondent Services | ✓ Optional | Separate role, can be same person or different | |
| 24/7 Emergency Support | ✓ Optional | Not required, but valuable for urgent situations | |
| Regulatory Consulting | ✓ Optional | Beyond basic U.S. Agent role |
"One U.S. Agent" Rule + Practical Implications
The regulation is clear: each foreign establishment gets one U.S. Agent. You can't designate multiple agents for the same establishment, and you can't split the role between different people. It's one agent per establishment, period.
But here's where it gets interesting: if you have multiple foreign establishments (say, a manufacturing facility in Germany and another in China), each establishment can designate its own U.S. Agent. They can be the same person or company, or they can be different. Many companies use the same regulatory service provider for all their establishments because it simplifies coordination and often comes with multi-site discounts.
You can change agents anytime—there's no lock-in period. If your current agent becomes unresponsive or you find a better option, you can switch through FURLS. The process takes 2-3 business days typically, but we've seen it take longer if the new agent is slow to confirm the receipt code.
The "agent" can be either an individual person or a business entity. Many companies prefer business entities (like regulatory service providers) because they offer team redundancy. If one person is unavailable, someone else handles communications. Solo consultants are cheaper but create a single point of failure—if they go on vacation or get sick, your FDA communications might sit unopened.
Practical implication: Since you only get one agent per establishment, choose carefully. This person or company becomes your single point of contact with FDA. If they're unreliable, you'll miss communications. If they're slow, you'll have delays. If they close their business, you'll have to scramble to find a replacement. That's why many companies pay a bit more for team-based providers with documented backup systems.
One edge case worth knowing: if you're a contract manufacturer working with a specification developer, each of you needs your own U.S. Agent. The specification developer can't serve as the contract manufacturer's agent, and vice versa. Each establishment must have its own designation, even if you're in the same supply chain.
Official Correspondent vs U.S. Agent
These are two distinct roles in FURLS, often confused:
- personU.S. Agent (21 CFR 807.40): Required for foreign establishments. Receives FDA communications.
- personOfficial Correspondent: Optional role. Person authorized to submit registration/listing data.
- checkCan Be Same Person: The same individual can serve as both U.S. Agent and Official Correspondent
- swap_horizCan Be Different: Many companies use different people for each role
Learn more: U.S. Agent vs Official Correspondent: What's the Difference?
Compliance Checklist You Can Copy
Use this checklist to verify your U.S. Agent meets 21 CFR 807.40 requirements:
- check_boxAgent is physically located in the United States
- check_boxAgent has a valid U.S. address (not a PO box)
- check_boxAgent is available during U.S. business hours
- check_boxAgent has documented forwarding procedures
- check_boxAgent has response time SLA (same-day or 24-hour)
- check_boxAgent has escalation procedures if communications are missed
- check_boxAgent understands FDA communication types (inspections, recalls, etc.)
- check_boxAgent has experience with medical device establishments
When to Use a Specialist Agent vs Generic Mailbox Agent
Not all U.S. Agents are created equal. Consider your needs:
- businessSpecialist Regulatory Provider: Better for complex needs, inspection support, multiple establishments, or when you need regulatory guidance
- mailGeneric Mailbox Service: May work for simple setups with low communication volume, but often lacks regulatory expertise
- warningRisk Factors: Generic services may miss urgent communications, lack inspection coordination, or have poor escalation procedures
- recommendRecommendation: For medical devices, a specialist regulatory provider typically offers better value and compliance assurance
Sources: FDA + CFR Links
We are a comparison platform; providers respond directly. All information on this page is based on official FDA regulations and guidance documents.
Frequently Asked Questions
Does 21 CFR 807.40 apply to all foreign establishments?
Yes. 21 CFR 807.40 requires all foreign medical device establishments to designate a U.S. Agent before completing establishment registration. This includes manufacturers, contract manufacturers, specification developers, repackers, relabelers, and initial importers.
Who can serve as a U.S. Agent under 21 CFR 807.40?
Any person (individual or business) physically located in the United States can serve as a U.S. Agent, provided they have a valid U.S. address (not a PO box) and are available during business hours. This can include importers, regulatory consultants, law firms, or dedicated U.S. Agent service providers.
What are the address requirements for a U.S. Agent?
21 CFR 807.40 requires the U.S. Agent to have a physical U.S. address. PO boxes are not acceptable. The address must be a real location where FDA can send mail and where someone is available during business hours to receive communications.
Can I switch U.S. Agents after registration?
Yes, you can change your U.S. Agent at any time through FURLS. However, you must ensure the new agent receives the notification receipt code and that all FDA communications are properly forwarded during the transition period.
What happens if my U.S. Agent doesn't respond to FDA?
If your U.S. Agent fails to respond to FDA communications, it can delay inspections, registrations, and regulatory actions. FDA may consider your establishment non-compliant. It's critical to choose a reliable agent with documented response time SLAs and escalation procedures.
Is audit readiness affected by U.S. Agent choice?
Yes. A responsive U.S. Agent who properly forwards FDA communications helps ensure you're prepared for inspections and can respond to FDA inquiries promptly. An unresponsive agent can create gaps in communication that affect your audit readiness and compliance status.
Related Resources
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