US FDA registration is the registration of your manufacturing, processing, packing or holding facility, and in some cases your listed products, with the US Food and Drug Administration so that your food, cosmetics, drugs or medical devices can be imported into the United States. It is a registration, not an approval or certification, and FDA does not issue a registration certificate. This page explains which products need registration, the role of the FEI number, DUNS number and US agent, the renewal windows, and what Indian exporters should check beyond registration itself.
What is US FDA registration?
The US Food and Drug Administration regulates food, drugs, medical devices, cosmetics and some other products sold in the United States. A foreign facility that manufactures, processes, packs or holds such products for US consumption must generally register with FDA. For food, this requirement comes from the Bioterrorism Act of 2002, which FDA's own pages describe, and the Food Safety Modernization Act of 2011 added biennial renewal and inspection assurance. FDA can suspend the registration of a food facility in certain circumstances.
Registration differs by product. Food facilities register through FDA's online system and renew every two years. For cosmetics, the Modernization of Cosmetics Regulation Act (MoCRA) requires facility registration and product listing: facilities renew every two years from initial registration, the responsible person lists each product with its ingredients and updates the listing annually, and a facility needs an FEI number. FDA states that it does not issue a certificate of registration for cosmetics, and small businesses may be exempt except for certain higher-risk products such as those for the eye area, injected, for internal use or that change appearance for more than 24 hours. Device establishments register annually under 21 CFR Part 807 and list their devices, and FDA collects an annual establishment registration fee.
Three identifiers keep appearing in this process. The FEI (FDA Establishment Identifier) number identifies a facility in FDA's systems. A DUNS number from Dun & Bradstreet is used to identify the facility's location in the registration. A US agent is a person or company residing or maintaining a place of business in the United States who acts as FDA's communication link with a foreign facility. FDA's food registration pages mention a Voluntary Identification System for US agents. The agent requirement for foreign facilities and the DUNS requirement come from FDA regulations and guidance; confirm them in the current forms when you file.
The most important point for Indian exporters is the status of registration. FDA does not approve or certify facilities simply because they have registered, and FDA says it issues no registration certificate for cosmetics. Documents advertised as an FDA certificate or FDA approval for a registered facility are not issued by FDA. Registration is the legal first step, and the facility still has to comply with product-specific rules such as food safety requirements, labelling, prior notice of food shipments and premarket requirements for certain devices and drugs.
Who needs US FDA registration?
Foreign facilities that make, process, pack or hold FDA-regulated products for the US market need to check registration. Typical Indian cases include:
- Food and beverage manufacturers and packers exporting to the US, such as spice, snack, sauce, tea, rice and processed food units
- Cosmetic manufacturers and processors, and the brand owners who act as the responsible person for listing products
- Medical device manufacturers who export finished devices, components or accessories to the US
- Drug manufacturers, including active pharmaceutical ingredient and finished dosage form facilities, whose registrations follow the drug establishment rules
- Warehouses and third-party packers that hold food or other regulated products for the US market
- Indian exporters who sell through a US importer, where the importer asks for the facility's FEI and registration number
Benefits of US FDA Registration for Indian Exporters
Legal entry to the US market
Where registration is required, shipments from an unregistered foreign facility face detention or refusal at the US port, so registering is a basic condition to export.
Identification in FDA systems
The FEI and registration details tie your facility to FDA's inspection, import screening and communication systems.
Importer and buyer confidence
US importers, distributors and marketplaces ask for registration and FEI details, together with product listings, before approving a supplier.
Better preparation for inspection
Preparing for registration pushes you to document your products, activities and contact points, which helps in an FDA inspection or an importer's audit.
Clear basis for compliance planning
Registration shows which other FDA requirements apply to your product, such as listing, labelling and food safety obligations.
Eligibility and applicability
The rules differ by product category. Before you register, confirm these points.
- Your facility manufactures, processes, packs or holds food, cosmetics, drugs or devices intended for the United States
- Food: a facility that is not exempt under the food facility rules; confirm exemptions in FDA's guidance for farms, retail and others
- Cosmetics: a facility that manufactures or processes cosmetic products for the US, subject to the small business exemption and its limits
- Devices and drugs: an owner or operator who must register the establishment and list the products, with the correct activity types
- A DUNS number for the facility, a US agent for a foreign facility, and an authorised person who has the facility's authority to submit the registration
- Product classification: whether the product is a food, a dietary supplement, a cosmetic, a drug or a device, because claims can change the category
Documents required
Facility and company information
- Legal name, address, phone and email of the facility and the parent company, if any
- DUNS number for the facility location
- Emergency contact details, which FDA expects for food facilities
- Authorisation of the person submitting the registration to act for the facility
US agent and importer information
- Name, address, phone and email of the US agent, together with the agent's consent to be named
- Details of the US importer or consignee, where the buyer asks for them
- Contract or service agreement with the US agent
Product and activity information
- Food: product categories handled and the type of activity such as manufacturing, processing, packing or holding
- Cosmetics: list of products with ingredients and the responsible person's details for product listing
- Devices: device list with product codes and premarket submission numbers such as 510(k), De Novo or PMA where required
- Existing FEI number, if the facility has one, and any prior FDA registration number
Step-by-step process
The sequence below summarises a typical registration. Screens and rules differ for food, cosmetics, drugs and devices, so use the FDA system for your product.
Classify the product and check the rules
Decide whether the product is a food, cosmetic, drug or device and check which registration, listing and premarket rules apply, including any exemption.
Obtain the DUNS number
Get a DUNS number from Dun & Bradstreet for the facility location. Use exactly the same name and address that will go on the registration.
Appoint a US agent
Choose a person or company in the United States who will be your FDA contact and accepts the role in writing. Put the agent's details in the registration.
Create the FDA account
Create an account in the relevant FDA system, such as FDA Industry Systems for food or the system for devices and drugs, and add the facility details.
Submit registration and listing
Complete the registration and, where required, product listing, then submit. Food registrations produce a registration number and a PIN that you need for later updates.
Record your FEI and registration number
Store the FEI and the registration number safely. US importers ask for them for each shipment, and FDA's import systems use them.
Pay the fee where applicable
Device and some drug establishments pay annual fees through FDA's payment system. Check the current fiscal-year fee before you register.
Renew and update on time
Food and cosmetic facilities renew every two years and devices every year. Update FDA within the stated time when your details, products or agent change.
Government fees
Fee rules differ by product. FDA's food facility pages we reviewed do not state a registration fee, and we have not verified fee rules beyond that. For medical devices, Congress has authorised FDA to collect an annual establishment registration fee, and for FY2026 FDA could waive the annual fee for certain small businesses certified through its Small Business Determination Program that show financial hardship. A report on FDA's Federal Register notice says FY2027 MDUFA fees are about 17 percent higher, effective 1 October 2026, but we have not verified the dollar amount.
| Item | Amount | Note |
|---|---|---|
| Food facility registration | Not verified; check FDA | FDA's registration pages reviewed do not state a fee. |
| Cosmetic facility registration and product listing | Not verified; check FDA | Verify on FDA's MoCRA pages. |
| Medical device annual establishment registration fee | Set each fiscal year by FDA | FY2027 fees reported effective 1 October 2026; confirm the exact amount on FDA's MDUFA fees page. |
Professional charges are quoted separately after reviewing your case. Government fees are paid directly to the authority.
How long does it take?
The online submission itself is quick once you have the DUNS number, US agent and complete facility and product details. Most delay comes from obtaining a DUNS number, finding a US agent and settling product classification. FDA does not run a fixed approval clock because registration is not an approval, and we do not promise a fixed timeline.
| Stage | Typical time |
|---|---|
| DUNS number and US agent appointment | Depends on the provider and your documents |
| Account creation and online submission | Once details are ready |
| Receipt of registration number and FEI details | Depends on the FDA system and product type |
Validity and renewal
Food facilities must renew their registration every two years, and FDA issued a reminder about the biennial renewal on 29 September 2026. The renewal period for food facilities is understood to run from 1 October to 31 December of even-numbered years, which includes the current year, but check this in FDA's current guidance. For cosmetics, facilities renew every two years from initial registration and product listings are updated annually. Device establishments register annually, and a failure to renew, or an FDA suspension of a food facility's registration, can lead to shipments being held at the border.
Compliance after registration
- Keep the US agent contract in force and update FDA when the agent changes
- Renew facility registrations on time and update listings when products or ownership change
- Comply with product-specific rules such as food safety standards, labelling, dietary supplement and cosmetic safety requirements, and premarket requirements for devices and drugs
- Make sure the US importer files prior notice for food shipments and meets importer duties under the Foreign Supplier Verification Program where it applies
- Keep records and be ready for FDA inspection, including foreign inspections, and respond to FDA communications through the agent
- Never describe the facility as FDA approved or certified, and do not use FDA logos on labels or promotional material
FDA registration by product category
| Food | Cosmetics (MoCRA) | Medical devices |
|---|---|---|
| Facility registration under the Bioterrorism Act | Facility registration and product listing under MoCRA | Establishment registration and device listing under 21 CFR Part 807 |
| Renewal every two years | Facility renewal every two years; listings updated annually | Registration renewed annually |
| No registration fee found in pages reviewed | FDA issues no certificate of registration | Annual establishment registration fee |
| US agent for foreign facilities | FEI number needed | Premarket submission numbers listed where required |
Common mistakes and rejection reasons
Believing registration is an approval
Exporters pay for an FDA certificate and print FDA approved on labels. FDA does not approve registered facilities, and such claims can make a product misbranded.
DUNS details that do not match
A name or address in the DUNS record that differs from the registration causes validation problems. Align both before you file.
Using an unreliable US agent
An agent who does not answer FDA queries puts shipments at risk. Choose an agent that can respond quickly and confirms the role in writing.
Missing the renewal window
Food facility registrations lapse if not renewed in the stated period, and shipments can be held until the registration is valid again.
Wrong product category
A product marketed with therapeutic claims may be a drug rather than a food or cosmetic, which changes the rules entirely.
Skipping other obligations
Registration does not replace labelling checks, prior notice, product listing for cosmetics or device premarket submissions.
Consequences of non-compliance
Shipments of regulated products from a facility that is required to be registered but is not can be detained or refused at the US port. FDA can suspend the registration of a food facility in certain circumstances. We have not listed US statutory penalty amounts because they depend on the violation and the current federal law, and are outside our verified scope here. For Indian-side consequences, exporters should also meet DGFT, customs and export rules.
Practitioner tips
- Start with the DUNS number and the US agent, because these take the longest and are needed in the form.
- Ask your US importer which FDA identifiers and documents they will want on each shipment, and prepare them in one folder before the first order.
- If you export food, cosmetics and devices from the same group, register each facility under the right product category and keep the activity descriptions accurate.
- Check your marketing claims against the category before registering. A claim that suggests treatment of a disease can move a product into the drug category.
- Diarise the renewal window now. This year, 2026, is an even-numbered year, so food facilities should confirm their renewal in the window FDA has announced.
How Lawgical Guru helps
Applicability and category check
We review your products and claims to identify whether they fall under food, cosmetics, drug or device rules and what registration applies.
Preparation of facility information
We help you assemble the facility, product and contact information and coordinate the DUNS number and US agent arrangement.
Registration support
We support the preparation of the online registration and keep a record of FEI and registration numbers for your files.
Export-side registrations
We support import export code registration, FSSAI licence, ICEGATE registration and GST registration for the Indian side of the export.
Related certifications
We assist with ISO certification, HACCP certification and CE certification that US and other buyers often ask for.
US FDA Registration for Indian Exporters: frequently asked questions
Is US FDA registration the same as FDA approval?
No. Registration records your facility and, where required, your products with FDA. It does not mean FDA has inspected, approved or certified the facility or product. FDA says it issues no registration certificate for cosmetics, and a certificate sold as FDA approval for a registered facility does not come from FDA.
Who needs to register with the US FDA?
Owners or operators of foreign facilities that manufacture, process, pack or hold food, cosmetics, drugs or medical devices for use in the United States need to check registration. Rules differ by product, and some small businesses or activities are exempt, so confirm applicability for your product.
What is an FEI number?
The FEI, or FDA Establishment Identifier, is the number FDA uses to identify a facility in its systems. FDA's cosmetics guidance says a facility needs an FEI number for MoCRA registration. US importers often ask for it when they file entries for your goods.
Is a DUNS number required for FDA registration?
FDA regulations and guidance for food facilities use a DUNS number to identify the facility location. We could not confirm this on the FDA page we reviewed, which did not state it, so check the current registration form. In practice you should have a DUNS number ready before you start.
Do I need a US agent?
A foreign facility generally needs a US agent, a person or company in the United States who acts as FDA's contact for the facility. FDA's food registration pages mention a voluntary system for identifying US agents. Confirm the requirement for your product in FDA's current guidance.
How often must I renew FDA registration?
Food facilities renew every two years, and FDA reminded facilities of the biennial renewal on 29 September 2026. Cosmetic facilities renew every two years from initial registration and update product listings annually. Medical device establishments register annually. Check the current window on FDA's site.
Is there a fee for FDA registration?
The FDA food facility pages we reviewed do not state a registration fee. Medical device establishments pay an annual establishment registration fee that FDA sets each fiscal year, with a possible waiver for certain small businesses. Check FDA's fee pages for the current amount for your product.
Does FDA issue a registration certificate?
For cosmetics, FDA states it does not issue a certificate of registration. You receive registration and identification numbers in the system. Third-party documents called FDA certificates are not government approvals, and you should not use them to claim FDA approval.
Can I use the words FDA approved on my label?
No, not on the strength of registration alone. FDA does not approve registered facilities, and using FDA approved or certified on a label can be misleading. Some drugs and devices do have FDA approval or clearance, but that depends on a separate premarket pathway and not on facility registration.
What else do I need to export food to the US?
Besides facility registration, food shipments require prior notice to FDA, normally filed by the importer or customs broker, and the US importer has duties under the Foreign Supplier Verification Program where it applies. Your labels and ingredients must also meet US rules. Check each with your importer.
Reviewed by Satyam Gupta, Company Secretary (CS) & Advocate
8+ years of industry experience. This page was last reviewed on 16 October 2026 against the official sources below. Rules and fees change — confirm on the official portal before you apply.