FDA U.S. Agent for IVD Manufacturers

IVD-Specific Considerations (Speed, Labeling Questions, Comms)

IVD manufacturers face unique challenges that other device types don't. Here's what I've learned from working with IVD companies over the years.

Speed requirements are often tighter. IVD registrations frequently have aggressive timelines—maybe you're launching a new test, or you need to register quickly to meet a contract deadline. A U.S. Agent who forwards communications within 48 hours might be fine for routine medical devices, but for IVDs, you often need same-day or 24-hour forwarding. We've seen IVD companies miss deadlines because their agent was slow to forward FDA communications.

Labeling questions come up frequently. FDA sends a lot of labeling-related questions for IVDs—maybe about intended use statements, performance claims, or warnings. These aren't just routine communications; they can block your registration if not addressed promptly. An agent who understands IVD labeling requirements can help prioritize these communications and ensure you see them quickly. Generic agents might forward everything with equal urgency, not recognizing what's blocking your registration.

Communication volume tends to be higher. IVD establishments often receive more FDA communications than other device types. If you have multiple IVD products, the volume increases further. Some agents are set up for low-volume forwarding (maybe 10-20 communications per year), but IVD companies might get 50-100+ communications annually. Make sure your agent can handle the volume without delays.

IVD-specific knowledge helps, but isn't required. An agent familiar with IVD regulations can better prioritize communications—they know labeling questions are urgent, they understand CLIA waiver processes, and they recognize what FDA is likely to ask about. This isn't required (any compliant agent can forward communications), but it's valuable. If you're choosing between two similar agents, pick the one with IVD experience.

Urgent communications are more common. IVD recalls or safety alerts require immediate forwarding. A basic agent who checks email once a day isn't enough. You need someone with 24/7 or emergency support, or at minimum, same-day forwarding guarantees. We've seen IVD companies miss recall deadlines because their agent didn't forward urgent communications promptly.

Multiple product lines increase complexity. If you have many IVD products (some companies have 50+), FDA communications can be overwhelming. Your agent needs to help you organize these—maybe categorizing by product type, prioritizing urgent items, or providing summaries. Basic forwarding services don't do this; they just forward everything blindly.

Typical Setups (Manufacturer + Importer + Distributor)

IVD manufacturers often work with multiple U.S. entities, which creates interesting setup choices. Here's what I've seen work well (and what doesn't).

Manufacturer + dedicated U.S. Agent is the most reliable. You use a dedicated regulatory service provider as your U.S. Agent, separate from your importer or distributor. This costs $800-1,500/year typically, but you get professional, consistent service. The agent understands FDA processes, forwards communications promptly, and doesn't disappear if your business relationships change. This is what I recommend for most IVD companies, especially if you're new to FDA registration.

Manufacturer + importer as U.S. Agent can work, but it's risky. Your U.S. importer serves as your U.S. Agent. This saves money (maybe $500-800/year instead of a dedicated provider), and it can work if your importer is reliable and you have a stable relationship. But here's the problem: 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. I've seen IVD companies miss renewal reminders this way.

Manufacturer + distributor as U.S. Agent has similar risks. Same idea as the importer setup—your distributor serves as U.S. Agent. Works if the relationship is stable, but risky if it ends. Distributors also tend to be less familiar with FDA regulatory processes than dedicated regulatory providers, so they might not prioritize communications correctly.

Manufacturer + regulatory firm is the premium option. A regulatory service provider serves as your U.S. Agent, and they often bundle additional regulatory support (helping with registrations, answering questions, providing guidance). This costs $1,200-2,000/year typically, but you get both communication forwarding and regulatory expertise. Worth it if you don't have internal regulatory staff or if you want professional support beyond basic forwarding.

My recommendation: For IVD manufacturers, especially those new to FDA registration, go with a dedicated regulatory service provider. The extra cost ($300-700/year more than using an importer) is worth the reliability and peace of mind. IVD registrations are complex enough without worrying about whether your agent will forward communications promptly.

Questions to Ask Providers (IVD Experience, Escalation)

Before selecting a U.S. Agent for your IVD establishment, ask these questions:

• helpIVD Experience: "Do you have experience serving IVD manufacturers? How many IVD establishments do you currently serve?"
• scheduleResponse Time SLA: "What's your guaranteed forwarding time for FDA communications? Same-day? 24 hours?"
• escalator_warningEscalation Procedures: "What happens if you miss a communication? Do you have backup systems?"
• labelLabeling Knowledge: "Are you familiar with IVD labeling requirements? Can you help prioritize labeling-related communications?"
• groupsTeam vs. Solo: "Is this a team operation or solo? How do you ensure redundancy?"
• calendar_todayInspection Support: "Do you provide inspection coordination support beyond basic forwarding?"
• attach_moneyPricing: "What's included vs. add-ons? Any multi-site discounts?"
• swap_horizSwitching Process: "What's your onboarding process? How quickly can you start?"