FDA U.S. Agent for Contract Manufacturers (and Sterilizers)

Multi-Entity Chains: Where U.S. Agent Fits

Contract manufacturing creates a complex web of relationships, and the U.S. Agent requirement adds another layer. Here's how it actually works in practice.

Each establishment needs its own U.S. Agent. This is the rule that trips people up. If you're a specification developer (the brand owner), you register your establishment and designate a U.S. Agent. Your contract manufacturer registers separately and designates their own U.S. Agent—it can't be the same person as yours, because they're different establishments. Same goes for sterilization facilities—if you use a separate sterilizer, they register separately and have their own agent.

But the same provider can serve multiple establishments. Here's where it gets interesting: while each establishment must designate its own agent, the same regulatory service provider can serve as agent for multiple establishments. So your specification developer establishment might use "Regulatory Firm A" as its agent, and your contract manufacturer might also use "Regulatory Firm A" as its agent. They're designated separately in FURLS, but it's the same company handling communications for both. This often comes with multi-site discounts and makes coordination easier.

The initial importer might also need registration. Depending on their role, your U.S. importer might also need to register as an establishment and designate a U.S. Agent. This creates even more complexity. Some companies use the same regulatory provider for all three (specification developer, CM, importer), which simplifies coordination but creates a single point of failure if that provider has issues.

Key point: One agent cannot serve multiple establishments unless they're the same legal entity. But the same regulatory service provider can serve multiple establishments, and many do. This is a common setup for multi-entity chains because it simplifies coordination and often comes with cost savings.

Practical example: Let's say you're a German specification developer working with a Chinese contract manufacturer. You register your German establishment and designate "Regulatory Firm A" as your U.S. Agent. Your Chinese CM registers separately and also designates "Regulatory Firm A" as their U.S. Agent. FDA sends communications to "Regulatory Firm A" for both establishments, but they're designated separately in FURLS. The firm forwards your communications to you in Germany, and the CM's communications to them in China. This works well because the same firm understands both relationships and can coordinate if needed.

Common Failure Modes (Unclear Ownership of Responses)

I've seen contract manufacturing setups fail in predictable ways. Here's what goes wrong and how to avoid it.

Missing forwarding is the most common problem. The CM's U.S. Agent receives an FDA communication (maybe a labeling question or inspection notice), but they don't forward it to the specification developer. Why? Because they think it's only relevant to the CM, or they don't have clear protocols about what to forward. Meanwhile, the specification developer is waiting for FDA's response, not knowing the communication is sitting in the CM's agent's inbox. This creates delays and can block registrations. The fix: establish clear forwarding protocols upfront. Define what gets forwarded to whom, and when.

Unclear recipients create confusion. FDA sends a communication to the CM's agent, but it's unclear who should respond. Is it a CM issue (manufacturing process) or a specification developer issue (device design)? Without clear protocols, communications sit unanswered while both parties assume the other is handling it. We've seen this delay registrations for weeks. The solution: define response ownership before selecting agents. Know who responds to what types of communications.

Delayed escalation compounds problems. An urgent FDA communication arrives at the CM's agent, but it doesn't get forwarded promptly. By the time the specification developer sees it, the deadline has passed or the issue has escalated. This is especially problematic for recalls or safety alerts, where timing matters. The fix: use agents with fast SLAs (same-day or 24-hour forwarding) and clear escalation procedures.

Agent unresponsiveness blocks everyone. If the CM's agent becomes unresponsive (maybe they went out of business, or they're just slow), it blocks both the CM and the specification developer. FDA communications sit unread, and neither party knows what's happening. This is why many companies prefer using the same reliable provider for all establishments—if one agent has issues, at least you know about it quickly.

Coordination gaps create duplicate work. The specification developer's agent and the CM's agent both receive similar communications, but they don't coordinate. Maybe both parties respond separately, creating confusion. Or maybe one responds while the other doesn't, leading to incomplete responses. The solution: use the same provider for all establishments, or establish clear coordination protocols if using different providers.

Relationship changes break communication chains. The CM relationship ends (maybe you switch manufacturers, or the CM closes), but the U.S. Agent designation wasn't updated. FDA keeps sending communications to the old CM's agent, who may or may not forward them. Meanwhile, you're not receiving FDA communications and don't know why. This is why it's critical to update agent designations immediately when relationships change.

The solution: Establish clear internal protocols before selecting U.S. Agents. Define who receives what, escalation procedures, and how to coordinate responses. Don't assume agents will figure it out—they won't. Put it in writing, and make sure all parties understand the process.

Provider Selection: SLAs, Accountability, Escalation

When selecting U.S. Agents for contract manufacturing setups, prioritize these factors:

• scheduleResponse Time SLA: Guaranteed forwarding time (same-day, 24 hours, 48 hours). Critical for multi-entity coordination
• account_boxAccountability: Named contact person, not just a generic email. Who's responsible if something goes wrong?
• escalator_warningEscalation Procedures: What happens if agent misses SLA? Backup systems? Redundancy?
• groupsTeam vs. Solo: Team operations offer better redundancy than solo consultants
• handshakeMulti-Entity Experience: Has provider served multiple establishments in the same supply chain? Can they coordinate?
• phoneCommunication Channels: Email forwarding only, or also phone/SMS for urgent matters?
• calendar_todayInspection Support: Beyond forwarding, do they help coordinate FDA inspections?
• attach_moneyPricing Transparency: What's included vs. add-ons? Multi-site discounts?