US FDA Agent Services — Your Statutory US Representative for FDA Compliance
Sub-headline: RABT Global provides US FDA Agent services for foreign medical device and pharmaceutical manufacturers under 21 CFR 807.40. Your legally required US FDA representative — managing FDA correspondence, establishment registration, and US market regulatory representation.
Statutory US FDA Agent services for foreign device and pharma companies. FDA compliance support services included as standard.
US FDA Agent services are a legal requirement for every foreign (non-US) medical device establishment and foreign drug establishment that imports products into the United States. Under 21 CFR 807.40 (medical devices) and 21 CFR 207.69 (pharmaceutical drugs), every foreign establishment must designate a US Agent — a US-based individual or entity who acts as the primary contact between the foreign establishment and the FDA.
At RABT Global, our US FDA Agent services provide the statutory US representation your establishment requires — combined with the regulatory expertise to manage FDA correspondence effectively. As your appointed FDA registration agent, RABT Global ensures that your FDA Annual Device Establishment Registration (ADER) is maintained, all FDA correspondence is received and managed promptly, and your US market regulatory representation is handled by qualified regulatory professionals.
Whether you are a medical device manufacturer, a pharmaceutical company, or a combination product developer importing to the US market, RABT Global’s US regulatory agent services are designed to keep your FDA compliance status current and your US market access protected.
RABT Global US FDA Agent — Scope of Services
| US FDA Agent Service | What is Included |
|---|---|
| US Agent Designation | Official designation of RABT Global as your US Agent in FDA systems (FURLS) |
| FDA Annual Registration Management | Annual Device Establishment Registration (ADER) renewal management |
| FDA Correspondence Management | Receipt and forwarding of all FDA correspondence within 24 hours |
| FDA Inspection Communication | Acting as the FDA contact for pre-announcement of facility inspections |
| Import Alert Support | Assistance with import alert identification and resolution |
| FDA Communication | Drafting and managing FDA communications on establishment registration matters |
| FDA Compliance Support | Proactive monitoring of FDA enforcement activity relevant to your product category |
| Medical Device vs Pharma Split | Specialist teams for device US Agent and pharmaceutical US Agent obligations |
What is a US FDA Agent?
A US FDA Agent (or US Agent) is a legally required US-based representative for foreign medical device and pharmaceutical establishments that import products into the United States. Under FDA regulations (21 CFR 807.40 for devices, 21 CFR 207.69 for drugs), foreign establishments must designate a US Agent who receives all FDA correspondence, facilitates communication with the FDA, and assists the establishment in fulfilling its US regulatory obligations. RABT Global provides statutory US FDA Agent services for foreign manufacturers worldwide.
US FDA Agent Services — FAQs
A: Under FDA regulations, any foreign (non-US) medical device establishment required to register with the FDA, and any foreign pharmaceutical establishment registered with the FDA, must designate a US Agent. This requirement applies regardless of the size of the company or the volume of product imported to the US market.
A: A US FDA Agent receives and forwards all FDA communications to the foreign establishment, assists the FDA in communications with the foreign establishment, and serves as the contact for FDA inspection pre-announcements. As your FDA communication agent, RABT Global ensures that all FDA correspondence is handled promptly and professionally — and that your establishment registration remains current.
A: Yes. RABT Global provides US FDA Agent services for both foreign medical device establishments (under 21 CFR 807.40) and foreign drug establishments (under 21 CFR 207.69). We have specialist teams for each, ensuring that the specific regulatory requirements for device and pharmaceutical US Agent obligations are met correctly.
A: A change of US Agent must be updated in FDA’s registration systems (FURLS). RABT Global manages this transition for you — updating your registration, notifying the FDA of the agent change, and ensuring continuity of FDA communication management during and after the transition. There is no gap in your US regulatory representation when you appoint RABT Global.
Appoint RABT Global as Your US FDA Agent
Statutory US Agent for FDA registration. FDA correspondence management. FDA compliance support services. US market regulatory representation for foreign device and pharma companies.