FDA U.S. Agent for Medical Device Establishment Registration

What an FDA U.S. Agent Is (Medical Devices)

Under 21 CFR 807.40, every foreign medical device establishment must designate a U.S. Agent—someone physically located in the United States who acts as FDA's primary contact point. Think of them as your regulatory mailbox and communication hub stateside.

Here's what this means in practice: When FDA needs to reach you—whether it's a routine renewal reminder, an inspection notice, or an urgent recall communication—they'll send it to your U.S. Agent's address. The agent then forwards everything to you, typically within 24-48 hours (though some providers guarantee same-day forwarding).

The agent must have a physical U.S. address—not a PO box or virtual mailbox. FDA explicitly prohibits PO boxes because they need someone who can receive mail during business hours. Many companies have learned this the hard way when their registration gets delayed because they tried to use a PO box address.

Beyond basic forwarding, many U.S. Agent providers offer additional services. Some help coordinate FDA inspection scheduling, which can be crucial if you're not familiar with U.S. inspection protocols. Others provide 24/7 emergency support for urgent FDA communications, which is especially valuable if you're in a different time zone.

Important distinction: The U.S. Agent is a communication conduit, not a regulatory consultant. They forward FDA's messages to you, but they don't replace your need for regulatory expertise. However, many regulatory service providers bundle U.S. Agent services with consulting, which can be helpful if you're new to FDA requirements.

This requirement exists because FDA needs a reliable way to reach foreign manufacturers. Without a U.S. Agent, FDA can't guarantee timely communication, especially during critical situations like recalls or inspections. That's why registration won't complete in FURLS until you've designated a valid U.S. Agent.

When Foreign Establishments Need a U.S. Agent

If you're a foreign company registering a medical device establishment in FURLS (FDA Unified Registration and Listing System), you'll hit a required field for U.S. Agent information. This isn't optional—FDA won't complete your registration without it.

The requirement applies broadly. Whether you're a manufacturer in Germany producing surgical instruments, a contract manufacturer in China making device components, or a specification developer in Israel who designs devices but contracts out production—you all need a U.S. Agent. The same goes for repackers, relabelers, and initial importers.

Here's a common scenario: A German manufacturer starts their FURLS registration, fills out all the establishment details, but then gets stuck because they haven't selected a U.S. Agent yet. They can't submit the registration until that field is complete. This is intentional—FDA wants to ensure they have a reliable contact before approving your registration.

Timing matters: You'll need to designate your U.S. Agent during the initial registration process. Some companies try to register first and add the agent later, but that won't work. The system requires it upfront. If you're switching from an old agent to a new one, that's a different process (you can do that anytime through FURLS), but for new registrations, it's mandatory from the start.

One edge case worth noting: If you have multiple foreign establishments (say, a manufacturing facility in China and a separate facility in India), each establishment needs its own U.S. Agent designation. However, you can use the same regulatory service provider for both—they just need to be designated separately in FURLS for each establishment.

What the Agent Actually Does (Communications + Scheduling Support)

In practice, your U.S. Agent becomes FDA's go-to contact for everything related to your establishment. When FDA sends a renewal reminder, an inspection notice, or—worst case—a recall notification, it lands in your agent's mailbox first, not yours.

The basic service is straightforward: they receive the mail, scan or forward it to you, usually within 24-48 hours. But here's where providers differ. Some just forward emails blindly. Others review communications, prioritize urgent items (like recalls), and may even call you if something looks critical. The difference can matter when you're dealing with time-sensitive FDA actions.

Inspection coordination is where many companies realize they need more than basic forwarding. When FDA schedules an inspection, they'll contact your U.S. Agent first. A good agent will help coordinate dates, understand your time zone constraints, and ensure you're prepared. A basic agent might just forward the inspection notice and leave you to figure it out. If you're in Asia and FDA wants to inspect next week, that coordination support becomes critical.

Emergency situations expose the difference between providers. Imagine FDA issues a recall notice at 3 AM U.S. time. A basic agent forwards it the next business day. A premium provider with 24/7 support might call you immediately, even if it's the middle of the night in your time zone. For recalls, those extra hours can matter.

Some providers go beyond the minimum. They'll help with registration renewals (reminding you when it's due, helping with the FURLS process), offer regulatory guidance on FDA communications, or even serve as your Official Correspondent (a separate but related role). These add-ons cost more, but they can save you time if you don't have internal regulatory staff.

One thing to remember: The U.S. Agent is a communication channel, not a regulatory expert. They forward FDA's messages, but they don't replace your need to understand FDA requirements or respond appropriately. If FDA asks a technical question about your device, your agent forwards it to you—they don't answer it for you.

How to Choose (Response Time, Address, Coverage, Escalation)

Picking the right U.S. Agent isn't just about checking a box in FURLS—it can impact how smoothly your FDA interactions go. Here's what actually matters when you're comparing providers.

Response time matters more than you might think. Most providers promise 24-48 hour forwarding, but that's a wide range. If FDA sends an urgent recall notice on Friday afternoon, a 48-hour SLA means you might not see it until Tuesday. Some providers guarantee same-day forwarding, and premium ones offer same-hour for urgent matters. The difference can be critical when timing matters.

Verify the address is real. This sounds obvious, but we've seen companies get burned. Ask for the physical address (not just a city), verify it's not a PO box, and ideally check that it's staffed during business hours. Some providers use virtual mailboxes or shared office spaces that aren't always staffed. FDA needs someone who can receive mail reliably—if mail sits unopened for days, that defeats the purpose.

Availability during U.S. business hours is non-negotiable. If your agent is in a different time zone and only checks email once a day, you'll have delays. Some providers offer 24/7 emergency support, which is valuable if you're dealing with recalls or urgent FDA actions. But even basic providers should be available during standard U.S. business hours (9 AM - 5 PM Eastern).

Ask about escalation procedures. What happens if your agent misses a communication? Do they have backup systems? Is there a team, or is it one person? We've heard stories of solo consultants who went on vacation and missed critical FDA communications. Teams offer redundancy—if one person is unavailable, someone else handles it.

Experience with your device type helps. While not required, an agent familiar with IVDs might better prioritize labeling-related communications. An agent who's never handled medical devices might forward everything with equal urgency, not recognizing what's truly urgent versus routine. Ask how many establishments they serve and whether they have experience with your specific device category.

Pricing transparency prevents surprises. Some providers advertise low annual fees but charge extra for every communication, setup, or cancellation. Others include everything in one price. Get clarity upfront: what's included, what costs extra, and what happens if you need to switch agents mid-year. Hidden fees can turn a $500/year service into $1,500/year quickly.

Common Mistakes That Delay Registration

We've seen companies make these mistakes repeatedly, and they all lead to the same outcome: registration delays, missed FDA communications, or compliance headaches. Here's what to avoid.

PO boxes don't work. FDA explicitly requires a physical address in 21 CFR 807.40, but some companies still try to use PO boxes. The registration system might accept it initially, but FDA will flag it during review, and you'll have to fix it. This adds days or weeks to your registration timeline. We've seen companies get all the way through FURLS registration only to have FDA reject it because the agent address was a PO box.

Unresponsive agents create problems. Some companies choose the cheapest agent without checking responsiveness. Then when FDA sends a time-sensitive communication, the agent doesn't forward it for days. By the time you see it, you've missed deadlines or created compliance issues. Test responsiveness during the sales process—if they're slow to respond to your questions, they'll likely be slow to forward FDA communications too.

Incomplete information causes rework. When filling out the U.S. Agent section in FURLS, make sure you have everything: full name (or business name), complete physical address, phone number, and email. Missing any of these will cause the system to reject your submission or FDA to request corrections. Double-check everything before submitting.

Not updating when switching agents. If you change U.S. Agents but don't update FURLS immediately, FDA will keep sending communications to your old agent. We've seen companies miss renewal reminders, inspection notices, and even recall notifications because they forgot to update the agent information. The old agent might forward things for a while, but that's not guaranteed, and it creates unnecessary risk.

Price shopping without considering service levels. The cheapest agent might be $200/year, but if they forward communications once a week instead of daily, that's a problem. Or if they don't have backup systems and go on vacation, your FDA communications sit unopened. Sometimes paying $100-200 more gets you significantly better service. Compare total value, not just price.

Ignoring inspection support needs. If you're a first-time registrant or unfamiliar with FDA inspection processes, choosing an agent who only forwards mail might not be enough. When FDA schedules an inspection, you'll need help coordinating dates, understanding what to expect, and ensuring proper communication. If your agent doesn't offer this support, you're on your own during a critical process.