US FDA Registration Services for Global Manufacturers
US FDA registration is the legal step by which a company that makes food, drugs, medical devices or cosmetics for the United States identifies its facility to the Food and Drug Administration. Each of the four product types has its own law, online system, renewal cycle and fee. A manufacturer outside the USA must also name a US Agent. Registration is not FDA approval. This guide compares the four routes and shows foreign manufacturers what to prepare.
Definition
What Is US FDA Registration?
US FDA registration is a notification, not a licence. The owner or operator of a facility tells the FDA who they are, where the facility is and what it makes. The FDA uses this information to plan inspections, to contact the company in an emergency and to check imports at the US border.
The duty comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act). It applies to facilities inside the USA and to facilities in any other country whose products are sold in the USA. Most registrations also require the products to be listed with the FDA, so “registration and listing” are usually completed together.
Scope
Which US FDA Registration Do You Need?
The route depends on what the facility makes, not on the size of the company. A company that makes products in two categories, for example a dietary supplement and a cosmetic, needs both registrations.
| Product type | Who registers | Law and regulation | FDA system | Fees | Renewal |
|---|---|---|---|---|---|
| FDA Food Facility Registration | Facilities that manufacture, process, pack or hold food, beverages or dietary supplements for the USA | FD&C Act section 415; 21 CFR Part 1, Subpart H | Food Facility Registration Module (FDA Industry Systems) | See food registration fee | Every two years, 1 Oct to 31 Dec of even-numbered years |
| FDA Drug Establishment Registration | Establishments that manufacture, repack, relabel or salvage drugs, including API and OTC products | FD&C Act section 510; 21 CFR Part 207 | Structured Product Labeling (SPL) files sent through FDA Direct | See drug registration fee | Every year, 1 Oct to 31 Dec |
| FDA Medical Device Registration | Manufacturers, specification developers, contract manufacturers, sterilisers, repackers, relabelers and initial importers of devices and IVDs | FD&C Act section 510; 21 CFR Part 807 | Device Registration and Listing Module (FURLS) | See device registration fee | Every year, 1 Oct to 31 Dec |
| FDA Cosmetic Registration | Facilities that manufacture or process cosmetics; the responsible person lists each product | FD&C Act section 607, added by MoCRA 2022 | Cosmetics Direct | See cosmetic registration fee | Facility every two years from first registration; product listing updated every year |
Important distinction
Is US FDA Registration the Same as FDA Approval?
No. Registration records that a facility exists. It does not mean the FDA has reviewed, tested, cleared or approved the facility or its products. The FDA states that a device registration and listing entry “does not denote approval, clearance or authorization” (FDA).
A registration or FEI/owner-operator number, an entry in the FDA database, and the legal basis to ship the registered product type to the USA once every other requirement for that product is met.
FDA approval, 510(k) clearance, permission to use the FDA logo, or an FDA certificate. The FDA does not issue registration certificates to device or cosmetic facilities. Any certificate you receive is issued by a private company.
Products that need a pre-market decision, such as most Class II devices or new drugs, follow a separate route explained on our FDA Approval Process page. For what a registration document can and cannot prove, see FDA Registration Certificate.
Outside the USA
How Do Foreign Manufacturers Register with the US FDA?
A company does not need a US office or a US company to register. It does need a US Agent: a person or business physically located in the USA that the FDA can contact about the facility. Foreign food facilities (21 CFR 1.232), foreign drug establishments (21 CFR 207.25) and foreign device establishments (21 CFR 807.40) must all name one. Foreign cosmetic facilities must also provide a US Agent contact under MoCRA.
The US Agent is named inside the registration, so the choice should be made before the application starts. I3CGLOBAL provides US FDA Agent Services for all four product types.
US FDA registration for Indian manufacturers
Indian exporters of pharmaceuticals, APIs, food products, spices, supplements, medical devices and cosmetics register from India through the FDA’s online systems. A DUNS number for the Indian site, a US Agent and an English product list are the usual starting points.
Manufacturers elsewhere in Asia
Contract manufacturers often supply several US brand owners from one site. The facility registers once; each brand owner or importer is then linked to it. Agreeing who files the listing avoids duplicate or missing entries.
Manufacturers in Europe
CE marking or an EU GMP certificate does not replace US FDA registration. Existing ISO 13485 or GMP documents help, but the facility must still register, list its products and name a US Agent.
Process
How Does the US FDA Registration Process Work?
The six steps below are common to all four routes. The system and the data fields change with the product type.
- Confirm the product categoryDecide whether the FDA treats the product as a food, drug, device or cosmetic. The intended use and the claims on the label decide this, not the name of the product.
- Appoint a US AgentRequired for every facility outside the USA. The agent confirms the appointment to the FDA.
- Find and check the DUNS number for the facilityThe FDA uses the DUNS number as the unique facility identifier. The name and address in the DUNS database must match the registration exactly; correct them, or obtain a number, before submitting.
- Create the FDA account and submit the registrationEnter the facility, owner, activities and product categories in the correct FDA system.
- List the productsDrugs, devices and cosmetics are listed individually. Devices that need 510(k) clearance or another pre-market decision can only be listed after that decision.
- Pay any FDA fee and keep the record currentRenew in the correct window and update the registration when the facility, products or US Agent change.
Documentation
What Information Does US FDA Registration Require?
| Information | Notes | Applies to |
|---|---|---|
| Legal name and physical address of the facility | Must match the DUNS record | All four routes |
| DUNS number | Free to obtain from Dun & Bradstreet | All four routes |
| Owner or operator and contact person | Name, email and telephone | All four routes |
| US Agent name, address, telephone and email | Facilities outside the USA | All four routes |
| Activities carried out at the site | For example manufacturer, packer, contract steriliser | All four routes |
| Product categories or product list | Food categories; drug listing with NDC; device product codes; cosmetic products with ingredients | Varies by route |
| Importers in the USA | Names are requested for drugs and devices | Drugs, devices |
| Labels | Needed for drug listing and useful for every route. See FDA Labeling Requirements | Drugs; recommended for all |
Maintenance
When Must US FDA Registration Be Renewed?
Three of the four routes share the same renewal window at the end of the calendar year. A registration that is not renewed is treated as expired, and shipments can then be refused at the US border.
| Route | Renewal window | Next deadline |
|---|---|---|
| Food facility | 1 October to 31 December, even-numbered years | 31 December 2026 |
| Drug establishment | 1 October to 31 December, every year | 31 December 2026 |
| Medical device establishment | 1 October to 31 December, every year, with the annual fee | 31 December 2026 |
| Cosmetic facility | Every two years from the date of first registration | Depends on the facility |
Avoidable problems
What Are the Common US FDA Registration Mistakes?
- Registering in the wrong category. A product sold with a treatment claim can be a drug or a device even if the company calls it a cosmetic or a supplement.
- Calling a registered product “FDA approved”. This is misleading and can lead to enforcement action.
- Naming a distributor as US Agent. If the business relationship ends, the registration is left without a valid agent.
- Address differences. The facility address in the registration, the DUNS record and the label should be the same.
- Missing the renewal window. The registration expires and must be made again.
- Registering the facility but not listing the products. For drugs, devices and cosmetics the two are separate tasks.
Getting started
How Do You Start US FDA Registration with I3CGLOBAL?
- Tell us what you makeSend the product names, intended use and the country of manufacture. We confirm which registration applies and the fees.
- Appoint the US AgentSign the agreement for registration and US Agent service.
- Find and check your DUNS numberLook up the DUNS number of your establishment and check that the name and address held in the DUNS database are exactly correct. If any detail has changed, or the establishment has no DUNS number yet, contact Dun & Bradstreet and arrange it before the registration is submitted.
- Send the facility and product detailsWe check them against FDA requirements before anything is submitted.
- We register, list and confirmYou receive the FDA registration details and a reminder before each renewal.
Work with I3CGLOBAL
How Does I3CGLOBAL’s US FDA Registration Service Work?
- We confirm the correct FDA product category before anything is submitted
- US Agent service for food, drug, medical device and cosmetic facilities outside the USA
- Facility registration and product listing in the correct FDA system
- Renewal reminders and updates when the facility, products or US Agent change
- Support for manufacturers in India, across Asia and in Europe
Start your US FDA registration
Send us your product list and facility details and we will confirm the route, the FDA fee and our service fee.
FAQs
US FDA Registration: Frequently Asked Questions
What is US FDA registration?
It is the mandatory notification of a facility to the US Food and Drug Administration by a company that makes food, drugs, medical devices or cosmetics for the US market. It identifies the facility and its products to the FDA. It is not an approval of the products.
Can a company outside the USA register with the FDA?
Yes. Foreign facilities register through the same online systems as US facilities. They do not need a US office, but they must name a US Agent located in the USA.
Can an Indian manufacturer register with the US FDA without a US company?
Yes. The Indian facility registers in its own name with its own DUNS number and appoints a US Agent. A US subsidiary or importer of record is not needed for the registration itself.
How much does US FDA registration cost?
It depends on the product type. Some routes carry an annual FDA fee and others carry none, and service and US Agent fees are separate. The current figures are on the fee page for each product type: food, drugs, medical devices and cosmetics.
Does the FDA issue a registration certificate?
No. The FDA does not issue registration certificates to medical device facilities or certificates that verify cosmetic registration. Certificates offered in the market are issued by private companies and have no official status.
How often must US FDA registration be renewed?
Drug and medical device establishments renew every year between 1 October and 31 December. Food facilities renew every two years in the same window of even-numbered years. Cosmetic facilities renew every two years from their first registration date.
Is a US FDA registration number the same as FDA approval?
No. The number shows that a facility is registered. Products that need approval or clearance, such as many medical devices and all new drugs, must go through a separate FDA review.
Who can act as a US FDA Agent?
Any person or business that lives or has a place of business in the USA and is available to answer the FDA during business hours. It cannot be a mailbox or an answering service.