U.S. 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

Agent changes must be reported to FDA within 30 days via an amended registration

LMG Service Fee

Competitive annual fee — fdahelp.us/fees

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 30 Days of Changes

Any changes to your registration — address, ownership, product lines, or agent designation — must be reported to FDA within 30 days. LMG handles all amendment submissions to keep your registration current.

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.

Frequently Asked Questions

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

What is a U.S. FDA Agent and why is it required?

A U.S. FDA Agent is a person or company physically located in the United States designated by a foreign establishment as the official communications link with FDA. It is a mandatory legal requirement under the Federal Food, Drug, and Cosmetic Act for all foreign establishments importing FDA-regulated products into the United States. FDA registration cannot be completed without designating a U.S. Agent.

Can a P.O. Box be used as the U.S. Agent address?

No. FDA regulations specifically prohibit the use of a P.O. Box as the U.S. Agent address. The agent must have a physical U.S. street address. LMG’s registered office at 75 Executive Drive, Suite 114, Aurora, Illinois fully satisfies this requirement for all clients.

Is the U.S. Agent responsible if my products are detained at a U.S. port?

No. The U.S. Agent’s role is limited to communications — they are not legally liable for product detentions, FDA violations, or compliance failures. Regulatory responsibility remains with the foreign manufacturer. LMG will promptly forward any import alert or detention notice and help coordinate your response to FDA.

Can LMG be our U.S. Agent for drugs, devices, AND food?

Yes. LMG provides U.S. Agent services across all four FDA-regulated product categories — drugs, medical devices, food and supplements, and cosmetics. Each product category requires a separate U.S. Agent designation in the corresponding FDA registration system, which LMG manages independently.

What happens if we change our U.S. Agent?

If you change your U.S. FDA Agent, the registration must be amended within 30 days of the change. LMG handles the full transition process for incoming clients — filing the amendment to update FDA’s records and confirming the new U.S. Agent designation.

How quickly can LMG be designated as our U.S. FDA Agent?

LMG can be formally designated as your U.S. FDA Agent within 1 to 2 business days after receiving your completed intake information and signed service agreement. For new registrations, LMG proceeds directly to preparing and submitting the FDA registration with the agent designation included.

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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