U.S. Agent Explained
A U.S. Agent is a person or entity physically located in the United States who is designated by a foreign establishment as their official point of contact with the FDA. The U.S. Agent must maintain a physical U.S. address (not a P.O. box) and be available during normal business hours to respond to FDA communications.
Under U.S. federal law, every foreign facility that manufactures, processes, packs, or holds FDA-regulated products intended for the U.S. market must designate a U.S. Agent. This requirement exists so the FDA always has a reliable domestic contact point — someone who can receive urgent communications, assist with inspection coordination, and forward critical notices to your facility in a timely manner.
Without a valid U.S. Agent, your FDA registration is incomplete and your shipments can be refused at the U.S. border. The U.S. Agent is not optional — it is a legal prerequisite for doing business in the United States in FDA-regulated product categories.
Who Must Have a U.S. Agent
U.S. Agent Requirements Under 21 CFR
What Regovant Does for You
When you designate Regovant as your FDA U.S. Agent, here is exactly what we do — included in your annual fee with no extras.
We receive, review, and forward all official FDA communications to you immediately — including inspection notices, deficiency letters, and urgent alerts. You are never caught off guard.
We file your initial FDA registration, maintain your account information in FURLS, and update your registration whenever required — product changes, address changes, activity changes.
We track all your FDA renewal deadlines and submit your renewals on time — before deadlines. You receive advance reminders. Your registration never lapses while you are with Regovant.
If the FDA requests an inspection of your facility, we coordinate scheduling on your behalf and help you understand what to expect — turning a stressful situation into a managed process.
Every service includes your official FDA Registration Number and a formatted Certificate of Registration — the document your importers, customs brokers, and buyers will ask for.
Warning Letter received? Import alert issued? Shipment detained? Our emergency response team mobilizes within 24 hours for active U.S. Agent clients — protecting your market access.
Transparent Pricing
Every price includes FDA registration, U.S. Agent designation, and your official Certificate of Registration. No hidden fees — ever.
Complete food facility registration under the Bioterrorism Act with Regovant as your designated U.S. Agent.
Annual device establishment registration and designated U.S. Agent service per 21 CFR Part 807.
Drug establishment registration, NDC Labeler Code assignment, and designated U.S. Agent for drug exporters.
Mandatory MoCRA facility registration with Regovant as your U.S.-based Responsible Person representative.
Simple Process
From order to registered U.S. Agent in as little as 3-7 business days.
Select your service on our pricing page and complete checkout securely via Stripe or PayPal.
Within 1 business day, our regulatory team contacts you to collect your facility information.
We prepare and submit your registration in FDA's FURLS system, designating Regovant as your U.S. Agent.
Your FDA Registration Number and official Certificate of Registration are delivered to you digitally.
Why Choose Regovant
Not all U.S. Agent services are equal. Here is how Regovant compares to typical alternatives.
Common Questions
Everything exporters need to know before designating a U.S. Agent for their FDA registration.
Already Have an Agent?
Many exporters stay with an underperforming U.S. Agent because they think switching is complicated. It is not. Here is exactly how the process works.
Reach out via our contact page or email. Tell us your current registration details and which product category you need covered.
Our team prepares all the updates needed in FDA's FURLS system to replace your current agent with Regovant.
Regovant completes the FDA agent consent process. The FDA updates its records. Your registration number stays the same.
From day one of the switch, all FDA communications come to Regovant. You are covered with no gap in service.
Thousands of exporters have made Regovant their trusted FDA U.S. Agent. The process is fast, the pricing is transparent, and the difference is immediate.
Get Started Today
Transparent pricing. Fast turnaround. Official Certificate of Registration included. Trusted by exporters in 60+ countries as their FDA U.S. Agent — for food, medical devices, drugs, and cosmetics.