US FDA Agent Services for Foreign Manufacturers

Every foreign food, drug, medical device and cosmetic facility must name a US FDA Agent before its FDA registration is complete. The US Agent is a person or company located in the United States who acts as the FDA's point of contact for your facility. MedDeviceCorp serves as your US FDA Agent, supports your FDA registration and keeps your facility listed and compliant every renewal cycle.

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What Does a US FDA Agent Do?

A US FDA Agent (also called an FDA US Agent) must live in the United States or keep a place of business there and be available during normal business hours. It cannot be a mailbox, answering machine or answering service. FDA treats information sent to your US Agent as if it were sent directly to your company, so choosing a reliable agent protects your registration and your shipments.

As your US FDA Agent, we:

  • Act as the FDA's communication link with your facility
  • Respond to FDA questions about your products and shipments
  • Help FDA schedule facility inspections
  • Forward FDA letters and requests to you without delay
  • Confirm our appointment in the relevant FDA registration system

Source: FDA – U.S. Agents

US Agent for Every Type of FDA Registration

The US Agent requirement applies across FDA product categories. The registration system, renewal cycle and agent duties differ for each.

Medical Device Establishment Registration

Foreign device manufacturers, specification developers and contract manufacturers must name one US Agent when they complete medical device establishment registration and device listing in FDA's FURLS system. Registration is renewed every year between October 1 and December 31, along with the annual establishment registration fee.

Medical device establishment registration →

Food Facility Registration

Foreign facilities that manufacture, process, pack or hold food for the US market need a US Agent for food facility registration. This covers dietary supplements and Ayurvedic products. Registration is renewed every even-numbered year between October 1 and December 31, and a Unique Facility Identifier (DUNS number) is required.

Food facility registration →

Drug Facility Registration

Foreign drug establishments must name a US Agent under 21 CFR 207.69 for drug facility registration. Registration is renewed every year. We support OTC monograph drugs, APIs, homeopathic medicines, testing laboratories and medicated topical products.

Drug establishment registration →

Cosmetic Facility Registration

Under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic facility registration and product listing are mandatory. Foreign facilities must include US Agent details when they register in Cosmetics Direct. Facility registration is renewed every two years.

Cosmetic facility registration →

FDA Registration Renewal Deadlines

Missing a renewal window can make your FDA registration inactive. Your US Agent must also be confirmed again when you renew.

  • Medical device establishments: every year, October 1 to December 31
  • Food facilities: every even-numbered year, October 1 to December 31 (FDA biennial renewal notice)
  • Drug establishments: every year, October 1 to December 31
  • Cosmetic facilities: every two years, with product listings updated each year

As your US Agent, we send renewal reminders before each window opens, so your FDA registration never lapses.

Documents Needed to Appoint a US Agent

Appointing a US Agent is quick when the following details are ready:

  • Legal company name, facility address and owner or operator details
  • DUNS number for the facility (we can help you obtain one)
  • Product category and a list of products to be registered or listed
  • Official correspondent and emergency contact details
  • Existing FDA registration number, if you are changing US Agent
  • A signed US Agent service agreement

How Our US FDA Agent Service Works

  1. Share your details – company, facility address and product category.
  2. Sign the US Agent agreement – a simple annual service contract.
  3. Prepare identifiers – we check or help you obtain a DUNS number.
  4. Complete FDA registration – your facility registration names MedDeviceCorp as US Agent.
  5. FDA confirmation – we accept the appointment in the FDA system.
  6. Ongoing support – FDA communication and renewal reminders every cycle.

What Happens Without a Valid US Agent?

If your US Agent does not confirm the appointment, cannot be reached or stops serving, FDA may treat your registration as incomplete. Shipments of your products can then be held or refused at the US port of entry. FDA letters, information requests and inspection notices may also go unanswered, which can lead to further compliance action.

A dedicated US Agent keeps your FDA registration active and your communication with FDA on time. Manufacturers selling in more than one market can also appoint us as their EU Representative or UK Responsible Person, and get support with FDA 510(k) submissions.

US FDA Agent FAQs

Who can act as a US FDA Agent?

Any person or company that lives in the United States or keeps a physical place of business there and is available during business hours. A mailbox or answering service does not qualify.

What is the difference between FDA registration and a US Agent?

FDA registration records your facility with FDA. The US Agent is the US-based contact that foreign facilities must name in that registration. A foreign facility cannot complete FDA registration without one.

Can my US importer or distributor be my US Agent?

Yes, if they meet FDA's requirements and agree to take on the role. Many manufacturers choose an independent FDA US Agent so their registration does not depend on a single distributor.

Do cosmetic facilities need a US Agent?

Yes. Under MoCRA, foreign facilities must include US Agent details in their cosmetic facility registration.

How often must FDA registration be renewed?

Medical device and drug establishments renew every year. Food facilities and cosmetic facilities renew every two years.

Does having a US Agent mean my product is FDA approved?

No. FDA registration and a US Agent are legal requirements for selling in the US. They do not mean FDA has approved or cleared your product.

Appoint MedDeviceCorp as Your US FDA Agent

Get your US Agent in place before your next FDA registration renewal window, and keep your shipments moving.

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