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US FDA Agent Service

Every foreign establishment importing drugs, medical devices, food, or cosmetics into the United States must designate a U.S. FDA Agent. LMG provides fast, reliable designation with full compliance support for all four FDA-regulated product categories.

Drugs & APIs Medical Devices Food & Supplements Cosmetics — MoCRA Since 2009
Regulatory Reference
U.S. FDA Agent — Requirements at a Glance
Legal Basis
21 CFR §1.227 (Food) · §207.69 (Drugs) · §807.40 (Devices) · MoCRA §607 (Cosmetics)
Physical Address
Must reside or maintain a physical place of business in the U.S. — P.O. Boxes not accepted
Availability
Must be reachable by phone during regular U.S. business hours for FDA communications
One Per Facility
Each foreign establishment may designate only one U.S. Agent per registration category
When Required
Before FDA registration can be submitted — the registration cannot be completed without a U.S. Agent
Changing Agents
Deadlines vary by category — 10 business days (devices), 30 calendar days (drugs), 60 days (food, cosmetics)
LMG Service Fee
Competitive annual fee — fdahelp.us/fees
The U.S. Agent is a communications intermediary only — not legally responsible for a facility's regulatory compliance or FDA violations.
4Product Categories
1–2Business Days
150+Countries Served
2009Est.

Who Must Designate a U.S. FDA Agent?

Any foreign establishment that manufactures, processes, packs, or holds FDA-regulated products for U.S. import must designate a U.S. Agent before submitting their FDA registration. This applies across all product categories regulated by FDA.

U.S. Agent Required For
  • Foreign drug manufacturers, repackers, and re-labelers exporting to the U.S.
  • Foreign API (Active Pharmaceutical Ingredient) manufacturers
  • Foreign medical device manufacturers, processors, and importers
  • Foreign food facilities manufacturing, processing, packing or holding food for U.S. import
  • Foreign cosmetic establishments under MoCRA
  • Foreign dietary supplement manufacturers
Generally Not Required For
  • Domestic U.S. establishments with a U.S. address already on file with FDA
  • Products manufactured outside the U.S. not intended for U.S. import
  • Foreign facilities solely engaged in R&D with no commercial U.S. products

Device Registration & Listing Services

LMG handles complete device establishment registration, device listing, and annual renewal for domestic and foreign medical device companies.

U.S. Agent for Drug & API Establishments

Foreign establishments that manufacture, repack, or re-label drug products — including prescription drugs, OTC drugs, biologics, and APIs — must designate a U.S. FDA Agent under 21 CFR Part 207 as part of their drug establishment registration.

The U.S. Agent serves as FDA's primary contact for all routine and emergency communications, including inspection coordination, warning letter delivery, and import alert notices.

Drug Registration Form Registration Guide →
What LMG Handles as Your Drug U.S. Agent
  • Drug establishment registration -SPL format
  • NDC Labeler Code request and assignment
  • Drug product listing (updated June & December)
  • Annual renewal management (Oct 1 – Dec 31)
  • Drug label review for 21 CFR compliance
  • Official Correspondent designation on request
  • FDA correspondence forwarding and response support
  • FDA inspection scheduling assistance
U.S. Agent for Medical Device Establishments

Any foreign medical device establishment engaged in manufacturing, preparing, or processing a device imported into the U.S. must designate a U.S. Agent under 21 CFR §807.40. The designation is submitted electronically through FDA's FURLS system as part of establishment registration.

The U.S. Agent has no responsibility to report adverse events under Medical Device Reporting regulations — that obligation remains with the manufacturer.

Device Registration Form Registration Guide →
What LMG Handles as Your Device U.S. Agent
  • Medical device establishment registration via FURLS
  • Annual renewal (Oct 1 – Dec 31)
  • Device listing updates and amendments
  • Official Correspondent service
  • 510(k) premarket notification support
  • UDI submission coordination
  • Device label review for FDA compliance
  • FDA inspection scheduling assistance
U.S. Agent for Food Facilities

Foreign food facilities manufacturing, processing, packing, or holding food for human or animal consumption imported into the U.S. must designate a U.S. FDA Agent under 21 CFR §1.227. The agent acts as the communications link for both routine and emergency FDA communications.

LMG's dedicated team ensures prompt response to all FDA inquiries on your facility's behalf during regular U.S. business hours.

Food Registration Form Registration Guide →
What LMG Handles as Your Food U.S. Agent
  • Food facility registration via FDA Bioterrorism Act system
  • Biennial renewal (Oct 1 – Dec 31, even-numbered years)
  • Prior Notice filing for U.S. food import shipments
  • Dietary supplement registration and compliance
  • FCE/SID for acidified and low-acid canned foods
  • Food label review for 21 CFR Part 101 compliance
  • FDA correspondence and emergency notification forwarding
U.S. Agent for Cosmetic Establishments — MoCRA

Under the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic establishments must designate a U.S. Agent as part of their facility registration and product listing with FDA. This applies to all foreign cosmetic manufacturers importing into the U.S.

The U.S. Agent receives and forwards all FDA communications to the foreign facility and assists with registration and listing compliance under MoCRA requirements.

Cosmetic Registration Form MoCRA Guide →
What LMG Handles as Your Cosmetics U.S. Agent
  • MoCRA cosmetic facility registration submission
  • Biennial facility registration renewal
  • Cosmetic product listing (annual update required)
  • Responsible Person designation support
  • Cosmetic label review for MoCRA compliance
  • TikTok FDA registration certificate
  • FDA Export Certificate for cosmetics

Why Choose LMG as Your U.S. FDA Agent?

Since 2009, LMG has served as the designated U.S. FDA Agent for hundreds of foreign establishments across all four product categories — physical U.S. office, dedicated staff, transparent annual fees.

Physical U.S. Address
LMG's registered office at 75 Executive Drive, Aurora, Illinois fully satisfies FDA's physical address requirement — no P.O. Box workarounds.
Available During U.S. Business Hours
LMG staff answer FDA calls and forward all communications to your facility promptly during regular U.S. business hours.
All 4 FDA Product Categories
One firm for drugs, medical devices, food & supplements, and cosmetics — one relationship for all your U.S. compliance needs.
Transparent Annual Fees
LMG's U.S. Agent fees are published on our website and have been price-locked since 2009. No hidden charges, no hourly billing.
Free Registration Certificate
LMG issues a certificate of FDA registration at no extra cost — verifiable by customers and importers at fdahelp.us.
150+ Countries Served
LMG works with foreign establishments from over 150 countries with deep experience across all regulatory requirements for U.S. import.

U.S. FDA Agent — Responsibilities & Scope

Understanding what a U.S. FDA Agent is and is not responsible for helps foreign establishments set correct expectations before designating an agent.

Primary FDA Communications Link
The U.S. Agent receives all official FDA correspondence — including inspection notices, import alerts, warning letters, and recall notifications — and forwards them to the foreign establishment without delay.
FDA Inspection Scheduling Assistance
When FDA needs to inspect a foreign establishment, the U.S. Agent assists in scheduling and coordinating the inspection, facilitating communication between FDA investigators and the facility's management team.
Registration Maintenance & Renewals
LMG proactively tracks all renewal deadlines — Oct 1 – Dec 31 annually for drugs and devices, biennially for food and cosmetics — and initiates renewals well in advance to prevent product detention at U.S. ports of entry.
Amendment Filing Within FDA’s Deadlines
Changes to your registration — address, ownership, product lines, or agent designation — must be reported to FDA on deadlines that differ by product category: 10 business days for medical devices (21 CFR 807.40(b)(3)), 30 calendar days for drugs (21 CFR 207.29(a)(3)), and 60 days for food and cosmetic facilities (21 CFR 1.234(a); MoCRA 607(a)(4)). LMG tracks each deadline and files the amendment so your registration never falls out of date.
Scope Limitation — What the U.S. Agent Is NOT Responsible For
The U.S. Agent is a communications intermediary only. The agent is not legally responsible for the foreign establishment's compliance, product safety, adverse event reporting, or FDA violations. Those obligations remain with the foreign manufacturer.

How the U.S. FDA Agent Designation Works

We manage the entire process from start to finish — so you can focus on your business.
1

Registration Form

You complete our simple registration form identifying your facility and product category.
2

Agent Update

We review your information and update your FDA registration with LMG as your official U.S. Agent.
3

Immediate Activation

Your U.S. Agent designation is active immediately — LMG becomes your official FDA contact.
4

Ongoing Service

We monitor FDA communications and relay all messages to your facility throughout the year.

Frequently Asked Questions

Common questions from foreign establishments comparing U.S. Agent providers — costs, switching, FDA’s requirements, and where the agent’s responsibility ends.

A U.S. FDA Agent is a person or company physically located in the United States that a foreign establishment designates as its official point of contact with FDA. The requirement applies to foreign facilities registering drugs and APIs (21 CFR 207.69), medical devices (21 CFR 807.40), food and dietary supplements (21 CFR Part 1, Subpart H), and cosmetics (MoCRA).

The agent reviews, routes, and responds to all FDA communications including emergency communications, answers FDA’s questions about products offered for import, and assists FDA in scheduling inspections of the foreign facility. FDA registration cannot be completed without a designated U.S. Agent.

One point is often missed: under both 21 CFR 207.69(b)(4) and 21 CFR 807.40(b)(2), if FDA cannot reach the foreign establishment directly or expeditiously, providing information or documents to the U.S. Agent is legally equivalent to providing them to the establishment itself. Your response deadlines start running when FDA contacts your agent, not when your agent contacts you.

At LMG, U.S. Agent service is included in the annual registration fee rather than billed separately:

  • Food, dietary supplement and nutraceutical facilities — USD 349 per year, covering FDA registration, U.S. Agent service, and a certificate of registration. No government fee.
  • Medical device establishments — USD 449 per year, plus FDA’s own annual establishment registration fee (MDUFA), which FDA sets each fiscal year and which is paid to the U.S. government. The FY2027 rate is USD 13,785.
  • Drug establishments — USD 649 per year, including NDC labeler code request and U.S. Agent service. No government fee.
  • Cosmetic facilities under MoCRA — USD 649 per year. No government fee.

These are flat professional fees with no hourly billing and no per-communication charges, and they have not increased since 2009. Government fees are paid to FDA directly and are never retained by LMG. Current figures for every service are published at fdahelp.us/fda-fees.

Six criteria separate a compliant agent from a compliance risk:

  1. A physical U.S. street address. 21 CFR 207.69(b) states the U.S. Agent “may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present.” P.O. boxes and mail drops do not qualify.
  2. A person reachable by phone during U.S. business hours. FDA expects to reach the agent directly, not a voicemail box or an overseas call centre.
  3. Coverage for your product category, and the ones you may add. Registering a drug with one agent and a device with another means two relationships, two renewal calendars, and two points of failure.
  4. A published flat annual fee. Hourly or per-communication billing creates a financial disincentive to forward FDA correspondence promptly.
  5. Proactive renewal tracking. Drug and device registrations renew annually between 1 October and 31 December; food and cosmetic registrations renew biennially. A lapsed registration commonly surfaces as detention at the port of entry.
  6. A clear exit. Confirm before you sign that the agent will file the amendment releasing the designation if you move. Your FDA registration belongs to your facility, not to your agent.

LMG meets all six: a staffed physical office at 75 Executive Drive, Suite 114, Aurora, Illinois; phone coverage Monday to Friday, 9:00 AM to 5:00 PM CST; all four FDA product categories under one firm; flat annual fees price-locked since 2009; proactive renewal management; and no restriction on transferring your designation to another agent.

Legally, yes — any person or company that resides or maintains a place of business in the United States may serve as your U.S. Agent. Commercially, it is usually a mistake.

Your U.S. Agent is FDA’s official channel to your facility and occupies a field on your FDA registration. If that agent is also your importer or distributor, then a pricing dispute, a change of distribution partner, or a contract renegotiation can put your FDA registration status in the hands of a commercial counterparty. FDA correspondence — inspection notices, import alerts, questions about your products — reaches them before it reaches you.

It also creates a practical problem: if you later change distributors, you must file a registration amendment to change your U.S. Agent at the same time, and you are dependent on the outgoing partner’s cooperation during a period when relations may already be strained.

Most foreign establishments appoint an independent regulatory firm so that the FDA relationship stays separate from the sales relationship and survives any change of commercial partner.

No. FDA’s drug regulations state it directly: under 21 CFR 207.69(b), the U.S. Agent “may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present.” FDA applies the same standard across product categories, and 21 CFR 807.40(b)(1) requires the agent to reside or maintain a place of business in the United States.

In practice this rules out four common shortcuts: a P.O. Box, a virtual-office or coworking mail address, a mail-forwarding service, and a state-law registered agent of the kind used for corporate filings, which is a different legal role entirely and carries no FDA responsibilities. The address on your registration must be a physical U.S. location where a person acting as your agent is actually present and reachable by telephone.

LMG’s registered office at 75 Executive Drive, Suite 114, Aurora, Illinois is a staffed physical office, and the same address is used for every client designation.

The consequences fall on your facility, not on the agent. There are three specific exposures:

  • Your registration may never issue. For foreign food facilities, FDA will not confirm the registration or release a registration number until the designated U.S. Agent affirmatively confirms that they agreed to serve (21 CFR 1.231). An unresponsive agent stops the registration before it starts.
  • Notice is treated as delivered regardless. Under 21 CFR 207.69(b)(4) and 21 CFR 807.40(b)(2), where FDA cannot reach you directly or expeditiously, information given to your U.S. Agent is legally equivalent to information given to you. Response clocks run whether or not the message is forwarded.
  • Shipments are held. Unanswered FDA questions about imported products, or a registration that lapsed because nobody tracked the renewal window, typically appear at the border as detention without physical examination.

Because the agent carries no legal liability for these outcomes, responsiveness is not something the regulations enforce for you. It is the single thing worth verifying before you designate anyone.

You can switch at any time. You do not need to wait for your renewal window, and you do not need your current agent’s permission or signature. Your FDA registration number and DUNS number stay the same — only the U.S. Agent field on the registration changes.

Send LMG your facility details and current registration number, and LMG prepares and files the amended registration. The designation is typically active within 1–2 business days.

The filing deadlines differ by product category, and the device deadline in particular is shorter than most establishments expect:

  • Medical devices — a change in the U.S. Agent’s name, address, or phone number must be reported within 10 business days (21 CFR 807.40(b)(3)).
  • Drugs and APIs — a change of U.S. Agent is an expedited update due within 30 calendar days (21 CFR 207.29(a)(3)).
  • Food and dietary supplement facilities — the registration must be updated within 60 calendar days of any change, including a change of U.S. Agent (21 CFR 1.234(a)).
  • Cosmetic facilities — FDA must be notified within 60 days of any change to the registration content, which includes the U.S. Agent contact (MoCRA section 607(a)(4)).

LMG tracks and files these on your behalf as part of the annual service.

No. The U.S. Agent’s role under the regulations is a communications role: reviewing and routing FDA communications, responding to FDA’s questions about products offered for import, and assisting FDA in scheduling inspections.

The agent is not the importer of record, does not assume liability for detentions, import alerts, refusals, or FDA enforcement actions, and is not legally responsible for your products’ compliance, safety, adverse event reporting, or labelling. Those obligations remain with the foreign establishment, and entry-related obligations sit with the importer of record.

What a competent agent does is make sure you hear about the problem the same day FDA raises it, and support you in preparing a response.

Ready to Designate LMG as Your U.S. FDA Agent?

LMG handles U.S. Agent designation for drugs, medical devices, food, and cosmetics — transparent fees and 1–2 business day turnaround.

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