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How Much Does a U.S. Agent Cost? Pricing Guide for Foreign Manufacturers

  • Writer: Paul Fitzgerald
    Paul Fitzgerald
  • 3 days ago
  • 5 min read

Published by US Compliance Agent LLC


One of the first questions foreign manufacturers ask when they learn about the U.S. Agent requirement is: how much does it cost? The answer depends on which agency you need an agent for, what services are included, and whether you are buying a standalone agent designation or a bundled consulting package.

This guide breaks down the real pricing landscape so you can make an informed decision.


The Short Answer


For a standalone U.S. Agent designation — meaning the address, phone number, correspondence forwarding, and designation letter without any consulting or registration assistance — expect to pay between $149 and $400 per year, depending on the agency.

If you buy from a firm that bundles the agent designation with regulatory consulting, label review, registration assistance, and other services, the price jumps to $500 to $1,500 or more.

The question is whether you need the bundle or just the agent.


Pricing by Agency


MoCRA / FDA Cosmetics U.S. Agent


Market range: $199 to $1,500 per year

At the low end, standalone agent services offer the designation, a U.S. address, and correspondence forwarding for $199 to $400 per year. At the high end, full-service regulatory firms bundle the agent designation with facility registration assistance, product listing help, label review, GMP consulting, and regulatory strategy — pushing the price to $500 to $1,500 or more.

Our price: $249/year — standalone agent designation with no bundled consulting.

Who pays the high end: Companies that do not have internal regulatory expertise and need someone to handle their entire MoCRA compliance program. The consulting is valuable for them, but the agent designation is a small part of what they are paying for.

Who pays the low end: Companies that already have a regulatory affairs team or work with a separate consultant. They know how to register in Cosmetics Direct. They just need the U.S. Agent box checked without paying for services they will not use.


FDA Medical Devices U.S. Agent


Market range: $299 to $3,000 per year

The medical device U.S. Agent market has been established longer than MoCRA and has more competitors. Standalone services range from roughly $299 to $500 per year. Firms that bundle the agent with 510(k) consulting, quality system management, and regulatory strategy charge $1,000 to $3,000 or more.

Our price: $349/year — standalone agent designation.

Important note: FDA charges a separate annual establishment registration fee for medical device facilities. This is paid directly to FDA and is separate from any agent service fee. The registration fee for foreign establishments changes each fiscal year — check FDA's website for the current amount.


FCC U.S. Agent


Market range: $300 to $500 per year

The FCC agent market is smaller and more specialized. Standalone agent services typically charge $300 to $500 per year. Some test laboratories include the agent service in their testing and certification package, which can be convenient but may lock you into a specific lab relationship.

Our price: $349/year — standalone agent designation.


NHTSA/DOT U.S. Agent


Market range: $300 to $500 per year

The NHTSA agent market is relatively small. Pricing is similar to FCC — standalone services in the $300 to $500 range.

Our price: $349/year — standalone agent designation.


EPA/TSCA U.S. Agent


Market range: $300 to $500 per year

Similar to NHTSA, the standalone EPA/TSCA agent service market is small. Pricing falls in the $300 to $500 range for a dedicated service.

Our price: $349/year — standalone agent designation.


Amazon INFORM / E-Commerce


Market range: $99 to $300 per year

This is the most commoditized market. Virtual mailbox services, LLC formation companies, and dedicated seller service providers all offer U.S. addresses for Amazon sellers. Pricing starts as low as $10 per month ($120/year) for basic virtual address services.

Our price: $149/year.

Important note: The INFORM Act does not actually require a U.S. address — it requires a "physical address" which can be in any country. A U.S. address for Amazon sellers is a commercial advantage, not a legal requirement. This is why pricing in this category is lower and more competitive.


What Should Be Included in the Price


Regardless of which agency you need an agent for, the following should be included in any agent service at no additional cost:

A verified U.S. physical address. This address appears on your agency registration or filing. It must be a real street address — not a P.O. Box.

A U.S. phone number. The agency needs a working phone number to reach your agent during U.S. business hours.

Correspondence forwarding. When the agency sends correspondence to your agent, the agent scans and forwards it to you. This should happen same business day.

Designation letter. A formal letter confirming the agent's acceptance of the designation, which you include in your registration or application.

12-month continuous coverage. The agent designation must be maintained as long as your products are in the U.S. market. Your annual subscription should cover the full year with no gaps.


What Should NOT Be in the Price (Unless You Want It)


Registration assistance. If you know how to register your facility in FURLS, Cosmetics Direct, or the FCC system, you should not have to pay for someone to do it for you as part of the agent service.

Label review. If you have your own regulatory affairs team handling labeling compliance, a mandatory label review bundled into your agent fee is unnecessary.

Consulting packages. Regulatory strategy, GMP auditing, safety substantiation, and other consulting services are valuable — but they are separate from the agent designation. Do not pay for them if you do not need them.

Per-item forwarding fees. Some providers charge additional fees for each document forwarded, each phone call received, or each piece of mail scanned. These fees can add up significantly over a year. Look for a flat annual fee with no per-item charges.

Setup fees. Some providers charge a one-time onboarding or setup fee. This is not unreasonable, but it should be disclosed upfront and should not be excessive.


The Real Cost Question: Bundle vs. Standalone


The pricing decision ultimately comes down to one question: do you need regulatory consulting, or do you just need the agent designation?

If you need consulting: Work with a full-service regulatory firm. Pay the $500 to $1,500. You are paying for expertise, not just a mailbox. The agent designation is a minor part of the package.

If you just need the agent: Work with a standalone agent service. Pay $149 to $349. You are paying for the address, the forwarding, and the availability — nothing more. This is the right choice if you have internal regulatory expertise, if you work with a separate consultant, or if you simply need the compliance box checked for a regulatory filing.

You should not pay full-service consulting prices for a standalone agent service. And you should not expect standalone agent pricing to include consulting services. Know what you need and pay accordingly.


Standalone U.S. Agent pricing versus bundled regulatory consulting package costs

Multi-Agency Discounts


If your company manufactures products that fall under multiple U.S. regulatory agencies — for example, a cosmetics company that also makes electronic beauty devices — you need separate agent designations for each agency.

Some providers, including US Compliance Agent, offer multi-agency coverage from a single provider. The operational benefit is one billing relationship, one point of contact, and consistent service quality across all agencies. Contact us for multi-vertical pricing if you need coverage for two or more agencies.


Our Pricing

Service

Annual Price

MoCRA Cosmetics U.S. Agent

$249

FDA Medical Devices U.S. Agent

$349

FCC Electronics U.S. Agent

$349

NHTSA/DOT U.S. Agent

$349

EPA/TSCA U.S. Agent

$349

E-Commerce / Consumer Products

$149

Transparent annual pricing for U.S. Agent designation services across FDA FCC and NHTSA

Every plan includes a verified U.S. mailing address, a U.S. phone number, same-day correspondence forwarding, a formal designation letter, and 12-month continuous coverage. No hidden fees, no mandatory consulting bundles, no per-item charges.

Visit our pricing page for details, or contact us to discuss your needs.



US Compliance Agent LLC is a private company. We are not affiliated with, endorsed by, or connected to the FDA, FCC, NHTSA, EPA, or any U.S. government agency. We do not provide legal advice, regulatory consulting, product testing, or certification services.

 
 
 

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