US FDA Agent & Official Correspondent
Required by FDA for every foreign medical device establishment. FDAmedix serves as your Officially Designated US FDA Agent and Official Correspondent — responsive, compliant, and priced well below what most companies are currently paying. Request a free rate comparison.
Request Free Consultation
Required by FDA. Too Important to Leave to Chance — and No Reason to Overpay For It.
If your company manufactures medical devices outside the United States, FDA law requires you to designate a US Agent. Most foreign establishments also need a properly designated Official Correspondent to manage FDA registration and listing. FDAmedix serves as your Officially Designated US FDA Agent and Official Correspondent — reliably, compliantly, and at a fraction of what many companies are currently paying their existing provider.
New to FDA registration, or ready to switch and save? Either way, we can help. Unlike most US Agent providers, FDAmedix isn’t just a mail-forwarding service — we’re a full-service medical device regulatory and quality consulting firm, so your Agent actually understands your compliance obligations.
What Is a US FDA Agent — and Why You Need One
Under 21 CFR 807.40, every foreign establishment that manufactures, prepares, or processes a medical device imported into the United States must designate a US Agent as part of its FDA Establishment Registration. This is not optional, and it is not a formality.
Official FDA Point of Contact: Your US Agent is the official communication link between your company and FDA — receiving inspection notices, Form 483s, warning letters, and other time-sensitive correspondence on your behalf.
Physical US Presence Required: Your US Agent must be a real person or company physically located in the United States — not a mailbox, an answering service, or a virtual address.
Inspection Facilitation: Your US Agent assists in scheduling and coordinating FDA inspections of your foreign establishment.
Registration Won’t Be Accepted Without One: FDA will not accept or renew your Establishment Registration until a qualified US Agent is on file. Without one, your devices can be refused entry at US ports.
Available When FDA Calls: FDA communications don’t wait for convenient business hours. Your Agent needs to be reachable and responsive — every time.
What Is an Official Correspondent — and How It Differs From a US Agent
The Official Correspondent is the individual or entity responsible for maintaining your FDA account, certifying the accuracy of your Establishment Registration and Device Listing, and serving as FDA’s routine administrative contact — separate from, but often paired with, the US Agent role.
Manages Your FDA Account: Maintains your registration in FDA’s Device Registration \& Listing Module (DRLM) and certifies that your listing information is accurate and current.
Handles Annual Renewal: Responsible for completing your annual Establishment Registration renewal and user fee payment on time, every year.
First Stop for Routine FDA Matters: Fields administrative questions, deficiency letters, and renewal reminders so they don’t fall through the cracks.
Can Be Combined With Your US Agent: FDA permits — and most companies prefer — appointing the same qualified organization as both US Agent and Official Correspondent, simplifying communication and reducing cost.
Accuracy Matters: Errors or gaps in your registration and listing information can delay renewals, trigger FDA follow-up, or jeopardize your ability to legally market your device in the US.
Two Ways We Help: New Registration or a Cost-Cutting Switch
First Time Registering With FDA? We’ll walk you through designation, documentation, and FURLS/DRLM setup from day one — so your Establishment Registration is accepted correctly the first time, without delays or rework.
Straightforward Onboarding: We collect what’s needed, complete your US Agent and Official Correspondent designation, and confirm everything is properly on file w ith FDA.
Guidance at Every Step:You’ll always know what’s required, what’s next, and what FDA expects — explained in plain language, not regulatory jargon.
Built for Long-Term Compliance: We set your account up correctly from the start, reducing the chance of renewal issues or missed deadlines down the road.
Already Have a US Agent or Official Correspondent? Switching is easier than most companies expect — and if you’re currently paying premium rates through another provider, the savings can be significant. We offer a deep discount over what most clients are currently paying for equivalent US Agent and Official Correspondent services — without cutting corners on responsiveness or compliance.
Simple Transition: We handle the update to your FDA registration information — required within 30 days of any change — so there’s no lapse in coverage.
No Disruption to Your Business: Your registration stays active throughout the switch. There is no gap in FDA representation.
Free Rate Comparison:Send us what you’re currently paying, and we’ll show you exactly what you’d pay with FDAmedix — most companies are surprised by the difference.
Not Just a Mailbox: A Regulatory Partner Who Understands Your Device
Most US FDA Agent providers do one thing: forward mail. They’re not regulatory consultants, and they have no expertise beyond receiving and relaying FDA correspondence. FDAmedix is different.
A Full-Service Regulatory Firm, Not a Registration Shop: Beyond US Agent and Official Correspondent services, FDAmedix supports medical device companies with QMS implementation, FDA mock audits, ISO 13485 certification consulting, EU MDR compliance, risk management, and MDSAP internal audits — see our full range of [Medical Device RA/QA Services](https://fdamedix.com/consulting-and-auditing-services/).
A Generic Agent Forwards Mail. We Respond: If FDA sends a warning letter, issues an import alert, or flags something during a registration renewal, a generic US Agent simply passes it along and leaves you to figure out what it means. An agent who understands 21 CFR 820, 807, and 803, and ISO 13485, can immediately pivot into gap analysis, CAPA support, or mock-audit remediation. That turns a compliance mailbox into an early-warning and response system — not just a delivery service.
Your Agent Understands What FDA Is Asking: When correspondence arrives — a Form 483, a deficiency letter, a request for information — you’re not just getting a forwarded email. You’re getting a team that can help you interpret it and respond correctly.
One Call Instead of Three Vendors: If a registration issue surfaces a deeper compliance gap, we don’t hand you off to another firm. We can move directly into gap assessment, CAPA support, or mock-audit remediation — because that’s already what we do.
The Same Expertise, Whether You’re Registering or Renewing: This isn’t a bolt-on service for us. It’s a natural extension of the regulatory work FDAmedix already does for medical device manufacturers every day.
Why Medical Device Companies Choose FDAmedix
Lower-Than-Industry-Standard Pricing: Consistent with everything else we do at FDAmedix, our US Agent and Official Correspondent services are priced well below typical industry rates — without sacrificing the responsiveness or regulatory expertise your registration depends on.
Real Regulatory Expertise, Not Just a Mailbox: As your Officially Designated US FDA Agent, our team understands 21 CFR 803, 806, 807, 820, and ISO 13485 — so when FDA reaches out, you get informed handling, not just a forwarded email. Responsive by Design: FDA communications are time-sensitive. We make sure nothing sits unanswered. Transparent, Predictable Annual Fees: No hidden charges, no surprise renewal invoices — just clear, competitive pricing you can budget around.
How to Get Started
Tell Us Where You Stand: Let us know whether you’re registering with FDA for the first time or currently working with another US Agent / Official Correspondent provider.
Get a Free Comparison: If you’re switching, share what you’re currently paying — we’ll show you our rate and the savings, with no obligation.
We Handle the Filing: Once you’re ready, we complete or transfer your designation, making FDAmedix your Officially Designated US FDA Agent and Official Correspondent of record with FDA.
Stay Compliant, Year After Year: We track your renewal deadlines and keep your registration current, so this is one compliance item you never have to worry about again. Whether this is your first FDA registration or your third US Agent, let’s make sure it’s handled right — and priced fairly.