21 CFR Part 807.40 · Foreign Establishment Requirement
Every foreign establishment that manufactures or distributes medical devices in the US must designate a US Agent before FDA registration can complete (21 CFR 807.40). Your US Agent receives FDA correspondence, serves as the point of contact for inspections, and manages your annual renewal window. ADB's US Agent is a senior FDA regulatory consultant — not a mailbox service.
Get Started TodayWhy FDA Requires This
Under 21 CFR 807.40, FDA requires every foreign establishment that must register to designate a US Agent — a person or firm residing or maintaining a place of business in the United States. The requirement exists so FDA has a domestic point of contact for every foreign manufacturer in the device database.
Your US Agent does three things: receives official FDA correspondence and forwards it promptly, serves as FDA's contact point for compliance and inspection-related communications, and manages your annual establishment registration renewal. Without a valid US Agent on record, your registration cannot be submitted — and an inactive or invalid Agent designation is treated as a registration deficiency.
ADB's differentiator: when FDA sends a correspondence item — an import alert inquiry, a facility inspection notice, a recall-related request — your ADB US Agent is a senior regulatory consultant who can read the document, assess its implications, and respond with regulatory judgment. That is not what you get from a $99 forwarding service.
Published Pricing
Fixed annual fees — no hourly billing. FDA's annual establishment registration user fee is set by FDA each fiscal year and is paid separately, directly to FDA — not to ADB.
US Agent / Official Correspondent
per year · foreign establishments
Registration + Listing + US Agent Bundle
flat fee · Year 1 · new foreign establishments
FDA annual user fee paid separately to FDA.
Need the full registration + listing service without the US Agent? See all FDA Device Registration packages →
Scope of Service
FDA defines the US Agent role precisely. Understanding the scope helps you evaluate whether you need additional services beyond the agent designation itself.
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Common Questions
Yes. Under 21 CFR 807.40, every foreign establishment required to register with FDA must designate a US Agent residing or maintaining a place of business in the United States. The US Agent is FDA's point of contact — receiving official correspondence, facilitating FDA access, and managing annual registration renewal. Failure to designate a valid US Agent is grounds for FDA to refuse registration and may result in import detention.
Legally, yes — if they have a US address and are reachable during normal business hours. However, 21 CFR 807.40 prohibits the US importer from simultaneously serving as the US Agent. Beyond the legal question, a sales-focused distributor may not respond promptly to FDA correspondence or manage your renewal window reliably. ADB's US Agent service is performed by the same senior regulatory consultant who knows your device and your establishment.
ADB's US Agent and Official Correspondent service is $595 per year. This covers agent designation in your FURLS registration, FDA correspondence handling, annual renewal submission, and renewal-window reminders (October 1–December 31). Budget mailbox services offer lower rates but provide no regulatory judgment — they cannot interpret FDA correspondence, identify a compliance issue, or respond with substantive expertise. ADB's consultant-led service is a different product.
They are related but distinct roles. The US Agent under 21 CFR 807.40 is the FDA-facing contact who receives correspondence on behalf of the foreign establishment. The Official Correspondent is the FURLS-registered individual responsible for submitting and maintaining the establishment's registration and listing records. ADB serves in both capacities under our flat-fee service — one senior contact handling all FDA registration activity for your establishment.
No. A US Agent under 21 CFR 807.40 handles FDA correspondence and annual registration renewal for foreign establishments distributing devices in the US commercial market. A US Sponsor of Record under 21 CFR Part 812 assumes full legal accountability for an Investigational Device Exemption clinical study — an entirely different regulatory obligation with no overlap. If you need both a US Agent for commercial distribution and a US sponsor for a clinical study, those are separate engagements. ADB provides both services independently.
All FDA medical device establishment registrations must be renewed annually during the October 1–December 31 renewal window. Missing this window causes your registration to lapse, which can result in your devices being detained at the US border. ADB tracks the renewal window for every US Agent client and submits renewal filings proactively — you do not need to manage this calendar yourself.
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Flat-fee $595/yr · Senior regulatory consultant · Official Correspondent included · Annual renewal managed.