Understanding the Need for a U.S. FDA Agent: A Guide for Foreign Manufacturers

Axentra compliance
Dec 19, 2025
7 min read

Updated: Jan 5

If you're a foreign manufacturer shipping products to the United States, understanding whether you need a U.S. FDA Agent is crucial. It can mean the difference between smooth market entry and detained shipments at the port. Yet confusion persists about when this requirement applies.

This article cuts through the ambiguity with specific regulatory citations and practical clarity for each product category. No generic overviews—just the facts that determine your compliance obligations.

The Core Principle: When Is a U.S. Agent Required?

Here's what most articles won't tell you upfront: The U.S. Agent requirement isn't triggered by shipment volume, frequency, or commercial value. It is triggered by facility registration requirements, which vary by product type.

If your foreign establishment must register with the FDA, you must designate a U.S. Agent as part of that registration. Period.

Medical Devices: 21 CFR 807.40

Registration Requirements

Every foreign establishment that manufactures or processes medical devices intended for U.S. distribution must:

Register the establishment with the FDA.
Designate a U.S. Agent.

This includes:

Class I, II, and III device manufacturers.
Contract manufacturers.
Repackagers and relabelers.
Sterilizers (if you sterilize devices for others).

The Critical Misconception

Myth: "My Class I device is 510(k)-exempt, so I don't need registration."

Reality: Device classification exemption from premarket notification does NOT exempt you from establishment registration. If your device requires listing with the FDA (which most do, regardless of class), you need registration and a U.S. Agent.

Example: You manufacture surgical gloves (Class I, 510(k)-exempt). You still must:

Register your establishment (21 CFR 807.20).
List your devices (21 CFR 807.22).
Designate a U.S. Agent (21 CFR 807.40).

When Registration Isn't Required (Rare Cases)

Devices solely for export that never enter U.S. commerce.
Component parts that will be incorporated into finished devices by U.S. manufacturers (if you're not marketing them separately).
Research/laboratory equipment not intended for clinical use.

Bottom line for devices: If you're shipping devices for U.S. sale or distribution, assume you need registration and a U.S. Agent unless you've confirmed a specific exemption with regulatory counsel.

Food Facilities: 21 CFR 1.101

Under the Bioterrorism Act of 2002, foreign facilities that manufacture, process, pack, or hold food for U.S. consumption must:

Register with the FDA.
Designate a U.S. Agent.

This includes:

Food manufacturers and processors.
Co-packers and contract manufacturers.
Warehouse facilities holding food destined for the U.S. market.
Dietary supplement manufacturers (regulated as food).

Specific Food Facility Scenarios

Low-Acid Canned Foods (LACF): If you produce LACF, you need:

Registration under 21 CFR 1.101 (Bioterrorism Act).
Separate registration under 21 CFR 108.35 (LACF-specific).
Your U.S. Agent represents you for both registrations.

Dietary Supplements: Treated as food facilities for registration purposes, but remember:

NDI (New Dietary Ingredient) notifications may be required separately.
Structure/function claims require notification.
Your U.S. Agent should understand supplement-specific requirements.

Foreign Supplier Verification Program (FSVP) Clarification:

Your U.S. Agent (represents your facility to the FDA) ≠ FSVP Importer (U.S. entity verifying your compliance).
These are separate roles, often filled by different entities.
Don't confuse the two.

When Food Facilities Might Not Need Registration

Farms (not engaged in manufacturing/processing).
Retail food establishments (restaurants, grocery stores selling direct to consumers).
Facilities shipping only to other facilities for further processing (if covered by another facility's registration).
Very small businesses meeting specific exemption criteria.

Important: Most foreign food manufacturers shipping to the U.S. DO need registration. Exemptions are narrow.

Drugs and APIs: 21 CFR 207.69

Under 21 CFR 207, foreign drug establishments engaged in manufacturing, repacking, relabeling, or salvaging drugs for U.S. distribution must:

Register the establishment (21 CFR 207.17).
Designate a U.S. Agent (21 CFR 207.69).
List their drugs (21 CFR 207.41).

This explicitly includes:

Finished dosage form manufacturers.
Active Pharmaceutical Ingredient (API) manufacturers.
Contract manufacturers.
Repackagers.
Biological product manufacturers.

The API Manufacturer Trap

Common mistake: "We only manufacture APIs for other companies. We don't sell finished drugs in the U.S., so we don't need registration."

Reality: If your APIs are used in FDA-regulated drug products destined for the U.S. market, you must register your establishment and designate a U.S. Agent.

The regulation is clear: API manufacturing is a covered operation under 21 CFR 207.

Contract Manufacturing Scenarios

Question: "We're a contract manufacturer. Our client holds the NDA/ANDA. Who needs registration?"

Answer: BOTH.

Your facility (the contract manufacturer) must register.
The NDA/ANDA holder must register their operations.
You each designate your own U.S. Agent (though the same agent can represent both if agreed).

OTC vs. Prescription Drugs

The registration requirement applies equally to:

Prescription drugs.
Over-the-counter (OTC) drugs.
Homeopathic drugs (unless specifically exempt).

No distinction based on marketing status for registration purposes.

Cosmetics: Section 607 of the FD&C Act (MoCRA)

Who Needs Registration and a U.S. Agent?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added new requirements. Foreign cosmetic facilities that manufacture or process cosmetics for U.S. distribution must:

Register each facility.
Designate a U.S. Agent.
Submit product listings.
Renew registration biennially (every two years).

MoCRA Small Business Exemption

Key exemption: Facilities with average annual U.S. cosmetic sales under $1 million (averaged over the previous 3 years) may be exempt from registration.

Critical details:

This is based on U.S. sales, not global revenue.
Calculate carefully using previous 3-year average.
If exempt from registration, you don't need a U.S. Agent (unless you voluntarily register).
If you voluntarily register despite exemption, you must designate a U.S. Agent.

Other MoCRA Exemptions

Registration is NOT required for facilities that ONLY manufacture:

Products that are also regulated as drugs or devices (unless they also make cosmetics not subject to drug/device requirements).
Products for professional use in licensed establishments (salons, spas) if certain conditions are met.

Important MoCRA Distinction

U.S. Agent vs. Responsible Person:

U.S. Agent: Represents your foreign facility to the FDA (required for foreign facilities).
Responsible Person: Name on product label, can be foreign or domestic entity.
These are different roles with different responsibilities.

Quick Decision Tree: Do You Need a U.S. Agent?

Ask yourself:

Are you a foreign establishment?
If NO → U.S. Agent not applicable.
If YES → Continue.

Are you manufacturing/processing FDA-regulated products for the U.S. market?
If NO → Likely no U.S. Agent needed.
If YES → Continue.

What product type?
Medical devices → YES, need U.S. Agent (21 CFR 807.40).
Food/dietary supplements → YES, need U.S. Agent (21 CFR 1.101).
Drugs/APIs → YES, need U.S. Agent (21 CFR 207.69).
Cosmetics → Check if small business exemption applies; if not exempt, YES need U.S. Agent.

Does a specific exemption apply? (See Article 2)
Canadian food exemption?
Transshipment only?
Research use only?
If legitimate exemption → May not need registration/agent.
If no exemption → Need U.S. Agent.

When the Requirement Is Actually Triggered

Timeline question: "When exactly do I need to have a U.S. Agent designated?"

Answer: Before your first commercial shipment to the U.S.

Best practice sequence:

Determine you need FDA registration.
Identify and contract with a qualified U.S. Agent.
Complete FDA registration with agent designation.
Receive registration confirmation.
THEN ship products.

Don't do it backwards. Some manufacturers ship products assuming they can register during transit. This leads to detention at the port.

Multiple Product Types: Do You Need Multiple Agents?

Scenario: Your facility manufactures both medical devices AND dietary supplements.

Answer: You need:

Device establishment registration with U.S. Agent (21 CFR 807).
Food facility registration with U.S. Agent (21 CFR 1.101).
The same agent can represent both registrations if they agree.

Key point: One agent can typically represent multiple establishments or registration types for the same legal manufacturer, but each registration must explicitly list the agent.

What About Foreign Establishments with U.S. Operations?

Question: "We have a manufacturing facility in Germany and a distribution center in the U.S. Do we still need a U.S. Agent for the German facility?"

Answer: YES. Your German facility (as a foreign establishment) still requires:

FDA registration.
U.S. Agent designation.

Your U.S. distribution center might serve as your U.S. Agent IF:

They meet all U.S. Agent requirements.
There's no conflict of interest.
They formally agree to agent responsibilities.

However, many companies prefer independent U.S. Agents to avoid conflicts.

Registration vs. U.S. Agent: Understanding the Relationship

Common confusion: "What's the difference between facility registration and U.S. Agent designation?"

Clarity:

Facility Registration: Your establishment's registration with the FDA (you're telling the FDA "we exist and make these products").
U.S. Agent: A required component of foreign facility registration (you're designating who represents you to the FDA).

You cannot complete foreign facility registration without designating a U.S. Agent. They're inseparable requirements.

The Volume Misconception

Persistent myth: "We only ship small quantities occasionally, maybe $10,000 worth per year. Surely we don't need full FDA registration and a U.S. Agent?"

Reality check: Registration requirements aren't based on commercial volume. A facility shipping $10,000 annually has the same registration obligation as one shipping $10 million.

Why this matters: The FDA's import screening doesn't distinguish shipment value. Your $5,000 shipment gets detained just like a $500,000 shipment if registration is missing or incorrect.

Key Takeaways

Medical devices, foods, drugs, and most cosmetics require U.S. Agent designation for foreign establishments.
The requirement is based on facility registration, not shipment volume or frequency.
510(k) exemption ≠ registration exemption for devices.
API manufacturers must register even if only selling to other manufacturers.
MoCRA created new cosmetics requirements with small business exemptions.
One agent can represent multiple registrations for the same manufacturer.
Registration must be complete before the first shipment.

What's Next?

Now that you know whether you need a U.S. Agent, the next question is: Do you qualify for any exemptions?

Our next article covers the 6 specific exemptions that could save you thousands in unnecessary compliance costs—including the narrow Canadian exemption, transshipment exceptions, and research use scenarios that most manufacturers don't know about.

[Read Article 2: 6 FDA Agent Exemptions That Could Save You Thousands (With CFR Citations) →]

Regulatory Citations Referenced

21 CFR 807.40 - U.S. Agent requirements for medical device establishments.
21 CFR 1.101 - U.S. Agent requirements for food facilities.
21 CFR 207.69 - U.S. Agent requirements for foreign drug establishments.
Section 607 of FD&C Act - Cosmetic facility registration under MoCRA.
21 CFR 108.35 - LACF facility registration.

Need help determining if your specific facility requires a U.S. Agent? The regulatory citations above provide definitive answers, but if you're still unsure, consult with a qualified regulatory professional before your first shipment.