Do I Need a U.S. Agent? A Quick Guide by Product Type
- Paul Fitzgerald
- 3 days ago
- 5 min read
Published by US Compliance Agent LLC
If you manufacture products outside the United States and sell them into the American market, there is a good chance you are required to designate a U.S.-based agent or contact for one or more federal regulatory agencies. But the requirements vary significantly depending on what you make.
This guide cuts through the confusion. Find your product type below and learn exactly which U.S. Agent designation applies to you, which agency requires it, and whether it is a hard legal requirement or a practical recommendation.
Cosmetics and Personal Care Products
Agency: FDA (under MoCRA — Modernization of Cosmetics Regulation Act of 2022)
Requirement: Mandatory. Every foreign facility that manufactures or processes cosmetic products for distribution in the United States must register with FDA and designate a U.S. Agent. Without a U.S. Agent, your facility registration cannot be completed, and your products may be refused at the border.
What counts as cosmetics under MoCRA: Skin care products, hair care products, makeup, nail care products, fragrances, bath products, oral hygiene products, baby care products, shaving products, and tattoo preparations.
Price: Our MoCRA U.S. Agent service is $249/year.
Medical Devices
Agency: FDA (under 21 CFR Part 807)
Requirement: Mandatory. Every foreign establishment that manufactures, processes, assembles, or packages medical devices for distribution in the United States must register with FDA annually and designate a U.S. Agent. This applies to all device classifications — Class I, Class II, and Class III.
What counts as medical devices: Surgical instruments, diagnostic equipment, implants, dental devices, ophthalmic devices, orthopedic devices, in vitro diagnostics, imaging equipment, patient monitoring systems, and any other article intended for use in the diagnosis, treatment, or prevention of disease.
Price: Our FDA Medical Devices U.S. Agent service is $349/year.
Electronics and Wireless Devices
Agency: FCC (under 47 CFR 2.911(d)(7))
Requirement: Mandatory for certification applications. Every foreign manufacturer seeking FCC equipment authorization (certification) must designate a U.S. Agent for service of process. The agent designation is submitted as part of the FCC application and must be signed by both the applicant and the agent.
What counts as electronics requiring FCC authorization: Smartphones, tablets, laptops, Bluetooth devices, Wi-Fi routers, smart home devices, IoT sensors, industrial wireless equipment, radio communication devices, and any product that intentionally or unintentionally radiates radio frequency energy.
Price: Our FCC U.S. Agent service is $349/year.
Motor Vehicles and Vehicle Equipment
Agency: NHTSA/DOT (under 49 CFR §551.45)
Requirement: Mandatory. Every foreign manufacturer of motor vehicles or motor vehicle equipment that is imported into or sold in the United States must designate a U.S. Agent who is a permanent resident of the United States.
What counts as vehicles and equipment: Cars, trucks, SUVs, motorcycles, buses, trailers, electric vehicles, tires, brake systems, lighting, child restraint systems, motorcycle helmets, and other safety-related automotive components.
Price: Our NHTSA/DOT U.S. Agent service is $349/year.
Chemical Substances
Agency: EPA (under TSCA — Toxic Substances Control Act)
Requirement: Contextual. While TSCA does not have a single, rigidly codified "U.S. Agent" requirement like FDA or FCC, foreign chemical manufacturers involved in TSCA submissions, reporting, or premanufacture notifications benefit from having a U.S.-based contact for EPA correspondence. The practical need is real even if the formal designation is less structured.
What counts as chemical substances under TSCA: Industrial chemicals, specialty chemicals, chemical intermediates, polymers, and other substances manufactured or processed for commercial purposes. TSCA does not cover pesticides (regulated by EPA under FIFRA), food additives, cosmetics, or pharmaceuticals (regulated by FDA).
Price: Our EPA/TSCA U.S. Agent service is $349/year.
Consumer Products (General)
Agency: CPSC (Consumer Product Safety Commission)
Requirement: No formal U.S. Agent designation under CPSC — but practical need is growing. CPSC does not have an FDA-style "U.S. Agent" registration requirement. However, with mandatory eFiling of Certificates of Compliance beginning July 8, 2026, foreign manufacturers of regulated consumer products face increasing compliance complexity and benefit from having a U.S. contact for CPSC correspondence.
What counts as CPSC-regulated consumer products: Children's toys, children's clothing, cribs, strollers, baby carriers, lighters, mattresses, fireworks, all-terrain vehicles, and other products subject to mandatory CPSC safety standards.
Price: Our consumer product U.S. contact service is $149/year.
Food and Beverages
Agency: FDA (under 21 CFR Part 1, Subpart H)
Requirement: Mandatory. Every foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with FDA and designate a U.S. Agent. This is a well-established requirement that has been in place since the Bioterrorism Act of 2002 and was strengthened by the FDA Food Safety Modernization Act (FSMA).
Note: US Compliance Agent does not currently offer standalone FDA Food Facility agent services as a primary vertical. The food agent market is well-served by established providers. If you need a food facility U.S. Agent, contact us and we can discuss whether our service is a fit for your situation.
E-Commerce / Amazon Sellers
Agency: FTC (under INFORM Consumers Act)
Requirement: The INFORM Act requires online marketplaces to collect, verify, and disclose information about high-volume third-party sellers — including a physical address. However, the law does not require a U.S. address specifically. Foreign sellers can comply with their home-country address.
What the law actually says: The INFORM Act says "physical address" — not "U.S. physical address." Amazon explicitly allows sellers from 102+ countries using their home-country addresses. A U.S. address is a commercial advantage (consumer trust, professional appearance) but not a legal requirement.
Price: Our e-commerce U.S. contact service is $149/year.
Products That Span Multiple Categories
Many foreign manufacturers produce products that fall under multiple U.S. regulatory agencies. Common examples:
Wireless medical devices — need both an FDA U.S. Agent (for the medical device registration) and an FCC U.S. Agent (for the wireless equipment authorization).
Cosmetics with electronic components — a beauty device with wireless connectivity may need both a MoCRA U.S. Agent and an FCC U.S. Agent.
Automotive electronics — a vehicle communication module may need both an NHTSA/DOT agent (as vehicle equipment) and an FCC agent (for wireless certification).
Consumer products sold on Amazon — a foreign manufacturer selling children's products on Amazon may need CPSC compliance support, an INFORM Act contact, and potentially an FDA agent if the product has cosmetic or drug claims.
If your products span multiple agencies, working with a single U.S. Agent provider simplifies your compliance administration. One contact, one billing relationship, consistent service quality across all agencies.
Quick Reference Table
Product Type | Agency | Requirement | Our Price |
Cosmetics / Personal Care | FDA (MoCRA) | Mandatory | $249/year |
Medical Devices | FDA (21 CFR 807) | Mandatory | $349/year |
Electronics / Wireless | FCC (47 CFR 2.911) | Mandatory | $349/year |
Vehicles / Auto Equipment | NHTSA/DOT (49 CFR §551.45) | Mandatory | $349/year |
Chemical Substances | EPA (TSCA) | Practical need | $349/year |
Consumer Products | CPSC | Growing need (eFiling 2026) | $149/year |
Food / Beverages | FDA (21 CFR Part 1) | Mandatory | Contact us |
Not Sure Which You Need?
If you are unsure which U.S. Agent designation applies to your products, contact us. Tell us what you manufacture and where you sell, and we will point you in the right direction — even if the answer is that you do not need our service.
US Compliance Agent LLC is a private company. We are not affiliated with, endorsed by, or connected to the FDA, FCC, NHTSA, EPA, CPSC, FTC, or any U.S. government agency. We do not provide legal advice, regulatory consulting, product testing, or certification services.
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