US FDA Agent Services
Your official US FDA Agent for food, drug, medical device, and cosmetic registration. Serving clients in 100+ countries since 1995.
US FDA Agent Services for Foreign Food, Drug, Device, and Cosmetic Companies
FDAbasics serves as your US FDA Agent for all four FDA-regulated industries: food, drugs, medical devices, and cosmetics. We receive and respond to all FDA communications on your behalf, assist with inspection scheduling, and keep your registration current year after year. We have served clients in 100+ countries since 1995, hold 5-star ratings on Trustpilot and Google, and charge $299 per year per facility, or $250 per year on a two-year agreement.
What Is a US FDA Agent?
A US FDA Agent is a person or company physically located in the United States that serves as the official point of contact between your foreign establishment and the FDA. The FDA sends all regulatory communications, including inspection notices, warning letters, compliance inquiries, and safety alerts, to your US Agent, not directly to your facility. Receipt by your US Agent is legally equivalent to receipt by your company.
Your US Agent must have a real US street address (not a PO box or answering service), be available to receive FDA communications during regular US business hours, and be prepared to respond to urgent notifications at any time. FDAbasics is headquartered in Brooklyn, New York, and meets all of these requirements for every industry we serve.
Who is required to appoint a US Agent ?
A US Agent is mandatory for any foreign establishment registering with the FDA. This includes:
- Foreign food and dietary supplement facility operators registering under Section 415 of the FD&C Act
- Foreign medical device manufacturers registering under Section 510 of the FD&C Act
- Foreign drug manufacturers (OTC, prescription, generic, API) registering under Section 510 of the FD&C Act
- Foreign cosmetic facility operators registering under MoCRA
- Foreign applicants of IND, NDA, ANDA, NADA, and ANADA submissions
- Companies submitting controlled correspondence to the FDA
- Companies submitting radiation reports to the FDA (FDA Accession number)
US Agent Requirements by Industry
US Agent appointment is required across all four FDA-regulated industries, but the specific legal basis and scope of responsibilities varies. FDABasics handles the full compliance picture for each — not just US Agent appointment. Learn more about how we can support you for each industry beyond US Agent services.
Food and Dietary Supplements
Required for all foreign food and dietary supplement facilities under Section 415 of the FD&C Act as amended by FSMA. The US Agent must be identified during registration and accepts all FDA communications including inspection notices. Legal basis: 21 CFR Part 1, Subpart H.
View all food services →Medical Devices
Required for all foreign device establishments under Section 510 of the FD&C Act. Each foreign establishment may designate only one US Agent. The US Agent assists the FDA in scheduling inspections and responds to questions about imported devices. Legal basis: 21 CFR Part 807.
View all device services →Drugs (OTC, Rx, Generic, API)
Required for all foreign drug establishments under Section 510 of the FD&C Act. The US Agent assists with registration, drug listing, and all FDA communications. Also required for foreign IND, NDA, and ANDA applicants. Legal basis: 21 CFR Part 207.
View all drug services →Cosmetics (MoCRA)
Required for all foreign cosmetic facilities registering under MoCRA. The US Agent assists with facility registration and annual product listing updates through the FDA Cosmetics Direct portal. Legal basis: FD&C Act Section 607 as amended by MoCRA.
View all cosmetics services →What the law requires of a US FDA Agent
Under 21 CFR 207.69(b) and parallel provisions for food, devices, and cosmetics, a US FDA Agent must: (1) be physically located in the United States with a real street address (not a PO box or answering service); (2) be available to receive FDA communications during regular US business hours; (3) review, disseminate, and respond to all FDA communications including emergency notifications; (4) assist FDA in scheduling inspections of the foreign establishment; and (5) accept FDA documents on behalf of the foreign establishment (receipt by the US Agent is legally equivalent to receipt by the foreign company). Failure to maintain a valid, active US Agent is a prohibited act under the FD&C Act and can result in shipment detention at US ports of entry.
How a US Agent works
When the FDA needs to reach your facility, it contacts FDAbasics first. Here is what happens:
Step 1: FDA sends a communication The FDA issues a notice, inquiry, inspection schedule, warning letter, or safety alert addressed to your establishment.
Step 2: FDABasics receives it We receive the communication, review it, and assess what action is required. Our team is based in Brooklyn, NY and is available during US business hours for routine communications.
Step 3: FDABasics responds We acknowledge receipt, prepare the appropriate response, coordinate inspection scheduling if required, and route urgent notices immediately. For drug companies, we handle all IND, NDA, ANDA, and DMF correspondence.
Step 4: You are notified We contact you with a clear summary of what was received, what action is needed, the timeline, and any next steps. You stay informed without having to manage the FDA directly.
What FDAbasics Handles as Your US Agent
- Accepts and manages all official FDA communications on your behalf
- Assists the FDA in scheduling inspections of your foreign establishment
- Assists with FDA food facility registration, drug establishment registration, and medical device registration*
- Assists with device listing and drug product listing (NDC number)*
- Assists with MoCRA cosmetic facility registration and product listing*
- Monitors and manages annual or biennial renewal deadlines for your registrations*
- Provides free registration assistance with active US Agent contract for food clients
- Provides US Agent appointment confirmation and documentation for your records
- Responds promptly to FDA inquiries - always available during US business hours
*These services may incur additional fees
Why Choose Our US FDA Agent Services
A US FDA Agent is a legal requirement for all foreign companies registering food facilities, drug establishments, medical device establishments, and cosmetic facilities with the US Food and Drug Administration. Your US Agent must be physically located in the United States, cannot be a post office box or answering service, and must be available during regular business hours to receive and respond to FDA communications. Choosing an experienced, responsive US FDA Agent is one of the most important decisions a foreign manufacturer makes when entering the US market.
- 30+ Years of FDA Regulatory Experience, serving clients since 1995
- Clients in 100+ Countries across all four FDA-regulated industries
- 5-Star Rated on Trustpilot and Google
- Food facility registration included at no extra charge with US Agent services
- No fees for listing additional devices or proprietary names
- Transparent, competitive fees with no hidden charges
- Strict client confidentiality.
- US-based team in Brooklyn, NY, meeting all FDA physical presence requirements
Your choice of US FDA Agent could mean the difference between a successful and unsuccessful process, so take the time to think through your needs. Our FAQ section on U.S. Agent requirements can help answer your questions.
FDAbasics offers a reliable and cost-effective solution for U.S. Agent services for small companies. Please refer to Google and Trustpilot ratings on the home page.
We’re ready to work with you! To appoint us as your US FDA Agent, fill in the online form, and complete the payment process. Once we’ve received your payment, we’ll start supporting your registration and regulatory communications. US Agent fees for drug companies involved in the filing of NDA, ANDA, NADA, and ANADA are based on the volume of regulatory submissions; please contact us.
Services and Fees
FDAbasics offers low-cost and reliable US FDA Agent Services for foreign companies.
| Service | Annual Fee | Need to Know |
|---|---|---|
| US Agent Services for Food, Dietary Supplements or Animal Food Products | $299/yr (or $250/yr for 2 yrs) | Per facility, Includes food facility registration assistance at no additional charge |
| US Agent Services for Medical Devices | $299/yr (or $250/yr for 2 yrs) | Per Facility. |
| US Agent Services for Drugs (OTC) | $299/yr (or $250/yr for 2 yrs) | Per Facility. IND, NDA, ANDA, NADA applicants: contact us for volume-based pricing |
| US Agent Services — Cosmetics (MoCRA) | $299/yr (or $250/yr for 2 yrs) | Per Facility. |
| US Agent — Controlled Correspondence | Contact us for pricing | For submissions of controlled correspondence to the FDA |
| US Agent — Radiation Reports | Contact us for pricing | For companies submitting FDA radiation reports (FDA Accession number) |
Frequently Asked Questions
Q: What is a US FDA Agent and what do they do?
A US FDA Agent is a person or company physically located in the United States that serves as the official point of contact between your foreign establishment and the US Food and Drug Administration. Your US Agent receives and responds to all FDA communications on your behalf, assists the FDA in scheduling inspections of your facility, and accepts official FDA documents — meaning that delivery to your US Agent is legally equivalent to delivery to your company. The US Agent does not have authority over your business decisions, but plays a critical role in keeping your FDA registrations active and your products moving into the US market.
Q: Is a US FDA Agent required for all foreign companies?
Yes. Any foreign establishment that manufactures, processes, packs, or holds products for distribution in the United States is required to designate a US FDA Agent as part of the registration process. This applies to food and dietary supplement manufacturers, medical device manufacturers, drug and API manufacturers, and cosmetic manufacturers registering under MoCRA. A foreign company cannot complete FDA registration without first designating a US Agent.
Q: Can my US distributor serve as my US FDA Agent?
Technically yes, but it is generally not recommended. Distributors are in the business of selling your products and are not trained in FDA regulatory compliance. If the FDA contacts your distributor about a compliance issue, inspection, or product recall, your distributor may not know how to respond correctly, and a misstep can have serious legal and business consequences. It is strongly advisable to use a dedicated FDA regulatory service provider as your US Agent rather than a distributor.
Q: Can I switch US FDA Agents if I am not satisfied?
Yes. You can change your US FDA Agent at any time by updating your FDA registration to reflect the new agent's information. When you appoint FDABasics as your new US Agent, we handle the agent change process on your behalf as part of onboarding at no additional charge. There is no penalty for switching agents.
Q: Can I be my own US FDA Agent?
Only if you have a physical presence in the United States. The FDA requires that a US Agent reside in the United States or maintain a place of business there, with a real street address (not a PO box or answering service), and be available to receive FDA communications during regular US business hours. Foreign companies without a US office cannot serve as their own US Agent.
Q: What happens if I do not have a US FDA Agent?
Without a valid, active US Agent, your FDA registration cannot be completed or maintained. For food facilities, your registration will be considered incomplete, and your products may be detained at US ports of entry. For medical devices and drugs, your establishment registration will be inactive, preventing you from importing products or submitting new applications to the FDA. Failure to maintain a US Agent is a prohibited act under the Federal Food, Drug, and Cosmetic Act.
Q: How do I change my US FDA Agent?
You can change your US FDA Agent at any time by updating your FDA registration to reflect the new agent's name and contact information. For food facilities, this is done through your FDA Industry Systems (FIS) account. For medical device establishments and drug establishments, the update is submitted electronically through the FURLS system. When you appoint FDABasics as your new US Agent, we handle the agent change process on your behalf as part of our onboarding.
FDA Resources
- US Agents for Medical Device Establishments
- Food Facility Registration and US Agent Requirements
- Drug Establishment Registration — US Agent
- MoCRA Cosmetic Facility Registration — US Agent
- 21 CFR Part 207.69 — US Agent Responsibilities for Drugs