FDA U.S. Agent vs Official Correspondent
Confused about U.S. Agent vs Official Correspondent in FURLS? Understand the differences, when to use the same person vs separate roles, and compare qualified providers. Fast quotes, no spam.
Quick Answer (2–3 Sentences)
The U.S. Agent (mandatory per 21 CFR 807.40) is FDA's contact point—they receive all FDA communications and forward them to you. The Official Correspondent (optional) is the person authorized to submit your registration and device listing data in FURLS. These can be the same person (common setup) or different people (if you want to separate communication handling from FURLS submissions).
Side-by-Side Comparison Table
Understanding the differences helps you make the right choice for your establishment:
| Feature | U.S. Agent | Official Correspondent |
|---|---|---|
| Requirement | ✓ Required for foreign establishments (21 CFR 807.40) | Optional (but recommended) |
| Primary Function | Receive and forward FDA communications | Submit registration and listing data in FURLS |
| Location Requirement | Must be physically located in U.S. (not PO box) | No location requirement (can be anywhere) |
| FDA Contact | FDA sends all regulatory communications to U.S. Agent | FDA does not contact Official Correspondent directly |
| FURLS Access | No FURLS access required | Must have FURLS account and access |
| Can Be Same Person | ✓ Yes, same person can serve both roles | |
| Can Be Different People | ✓ Yes, you can designate different people | |
| Typical Setup | Regulatory service provider or importer | Regulatory consultant or internal regulatory staff |
Common Setups (Solo Consultant, Importer, Regulatory Firm)
Different companies structure this differently based on their size, risk tolerance, and existing relationships. Here are the most common patterns we see:
Solo consultant setup: One person handles both roles. This is the most cost-effective option, typically $500-800/year. It works well for small companies with low communication volume. The downside? If that consultant goes on vacation or gets sick, everything stops. We've seen companies miss FDA communications because their solo consultant was unavailable. If you go this route, make sure they have backup systems or at least check email daily.
Importer as U.S. Agent: Your U.S. importer serves as U.S. Agent, while you use a regulatory consultant as Official Correspondent. This can work if your importer is reliable and you have a good relationship. But here's the risk: if the importer relationship ends (which happens more often than you'd think), you're suddenly without a U.S. Agent. FDA keeps sending communications to the old importer's address, and you might not know until you miss something critical. We've seen companies miss renewal reminders this way.
Regulatory firm setup: A dedicated regulatory service provider handles both roles. This typically costs $800-1,500/year but offers better reliability. These firms usually have teams, so if one person is unavailable, someone else handles it. They also understand FDA processes better than generic mailbox services. For most companies, this is the sweet spot between cost and reliability.
Separated roles: Different people for each role. You might use a communication-focused service as U.S. Agent (someone who specializes in fast forwarding) and a regulatory consultant as Official Correspondent (someone who knows FURLS inside and out). This is more expensive (often $1,200-2,000/year total) but provides specialization. You only need this if you have complex needs or want maximum redundancy.
Our recommendation: For most small to medium companies, using the same person for both roles is simpler and more cost-effective. Just make sure they're reliable. If you're a larger company with multiple establishments or higher risk tolerance, separating the roles can provide better specialization and redundancy.
When to Separate the Roles (Risk + Response Time)
Consider separating U.S. Agent and Official Correspondent when:
- warningHigh Risk of Relationship Changes: If your importer is your U.S. Agent and the relationship might end, separate the roles to avoid disruption
- scheduleNeed Faster Response Times: A dedicated communication-focused U.S. Agent may respond faster than a consultant handling multiple tasks
- groupsWant Specialization: Use a regulatory consultant for FURLS submissions (Official Correspondent) and a communication service for FDA contact (U.S. Agent)
- securityRisk Management: Separating roles reduces single point of failure risk
- apartmentMultiple Establishments: If you have many facilities, separating roles can provide better organization
When to Combine: For most small to medium companies, using the same person for both roles is simpler, more cost-effective, and works well if you choose a reliable provider.
Questions to Ask Before You Choose
Before selecting your U.S. Agent and/or Official Correspondent, ask these questions:
- helpDo you offer both U.S. Agent and Official Correspondent services? (If yes, can they be the same person?)
- scheduleWhat is your response time SLA for forwarding FDA communications? (Same-day? 24 hours? 48 hours?)
- location_onDo you have a physical U.S. address? (Not a PO box or virtual mailbox)
- groupIs this a solo operation or a team? (Teams offer better redundancy)
- escalator_warningWhat happens if you miss a communication? (Ask about escalation procedures)
- calendar_todayDo you provide inspection coordination support? (Beyond basic forwarding)
- attach_moneyWhat's included vs. add-ons? (Understand pricing structure)
- swap_horizWhat's the process for switching? (If you need to change later)
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
Can the same person be both U.S. Agent and Official Correspondent?
Yes, the same person can serve as both U.S. Agent and Official Correspondent. This is a common setup, especially for smaller companies or when using a single regulatory service provider. However, you can also designate different people for each role if preferred.
What does FDA contact the U.S. Agent for?
FDA contacts the U.S. Agent for all regulatory communications related to your establishment, including inspection scheduling, recall notifications, registration confirmations, renewal reminders, and emergency communications. The U.S. Agent must forward these communications to you.
What happens if my U.S. Agent is unresponsive?
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. You should switch to a more responsive agent immediately and ensure all communications are properly forwarded during the transition.
What if my importer relationship ends?
If your importer was serving as your U.S. Agent and the relationship ends, you must immediately designate a new U.S. Agent through FURLS. Do not wait, as FDA communications will continue to go to the old agent's address, potentially causing compliance issues.
What are the cost implications of separating the roles?
Using the same person for both roles typically costs less than separating them. However, separating roles can provide better specialization (e.g., a regulatory consultant as Official Correspondent, a communication-focused service as U.S. Agent). Compare quotes for both setups to determine what works best for your needs and budget.
Related Resources
Explore more FDA U.S. Agent resources:
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