US FDA Registration for Indian Exporters
Any Indian facility that makes, processes, packs or holds food, drugs or medical devices for the US market must register with the US Food and Drug Administration and name a US agent. Food facility registrations must be renewed between 1 October and 31 December of every even-numbered year, and the 2026 window is open now. We prepare the registration, coordinate with your US agent and keep your renewals on time.
What it is
US FDA registration tells the American regulator who you are, where your facility is, what you make there and who it can contact in the US. Without it, food, medicines and medical devices from your site cannot lawfully enter the US market. It is not a product approval or a quality certificate.
For food, the requirement comes from Section 415 of the US Federal Food, Drug, and Cosmetic Act and the FDA’s rules in 21 CFR Part 1, Subpart H. Registration and renewal are done online through the FDA Industry Systems (FIS) account, also known as FURLS.
A foreign facility must name a US agent: a person or company that lives in or has a place of business in the US and is physically present there. The FDA checks with the agent before it confirms your registration.
Who it applies to
Food and spice exporters
Facilities that manufacture, process, pack or hold food or animal food for consumption in the US. Spices, snacks, rice and food ingredients are all covered. A facility is exempt if another facility outside the US processes or packs the food further before export, unless that later step is minor.
Pharmaceutical manufacturers
Drug establishments that make or process drugs for the US register every year and list their products. Foreign establishments must give the name and DUNS number of their US agent and of every US importer.
Medical device makers
Establishments that make or process devices for the US must register every year, list their devices and pay the FDA’s annual establishment registration fee.
Why it matters
Keep shipments moving
Food from a facility whose registration has expired or was never made can be held at the US port of entry. Your buyer bears the delay and remembers who caused it.
Stay on the right side of US law
Failing to register, renew, update or cancel a food facility registration is a prohibited act under Section 301(dd) of the US Federal Food, Drug, and Cosmetic Act.
Answer the buyer’s first question
US importers check your FDA registration number before they place an order. A lapsed number can end the conversation.
Documents required
About the facility
- Legal name and full address of the facility
- Owner, operator or agent in charge with contact details
- DUNS number for the facility address (the FDA’s accepted Unique Facility Identifier)
- Emergency contact
About your products
- Food product categories you handle
- Activity at the site: manufacturing, packing or holding
- For drugs and devices: product list and labeler details
US agent and Indian papers
- US agent’s name, full address, phone and email
- Written agreement with the US agent
- Import Export Code, GST registration and company documents
How it works
Confirm what you must register
We look at your products and the role of each site (making, packing or storing) and decide whether you need a food facility, drug establishment or device registration, or more than one. A Faridabad group that makes medical disposables in one unit and packs spices in another, for example, needs a device registration for the first and a food facility registration for the second.
Get the DUNS number and US agent in place
We help you obtain a DUNS number for the exact facility address and coordinate with a US agent who will accept the appointment. Here is the catch: the address must match letter for letter across DUNS, FDA and your agent’s records.
Submit and get FDA confirmation
We set up the FDA Industry Systems account and submit the registration with the facility, product and agent details, then follow up until the FDA confirms it with the agent.
Renew and update on time
We file updates within 60 days of any change and renew in the October to December window, so your number stays valid.
Timelines
Food facility renewal
Every two years, between 1 October and 31 December of each even-numbered year. The current window closes on 31 December 2026.
Drug and device establishments
Every year. Drug establishment registration is renewed between 1 October and 31 December. Drug listings are updated in June or December after a change.
Changes and closures
Food facility updates within 60 days of a change in information. Cancellation within 60 days if the facility closes or changes owner.
What happens if you miss the renewal
Registration expires
The FDA treats the registration of any food facility that does not renew by 31 December 2026 as expired, and will cancel it.
Food held at the port
Food from a facility without a valid registration can be held at the US port of entry until the matter is sorted out.
Fresh registration needed
Once cancelled, you register again and share the new number with every buyer. In practice, a Sonipat rice exporter who forgets the even-year renewal finds out only when a January shipment is stopped at the US port.
Food, drug and device registration compared
| Point | Food facility | Drug establishment | Device establishment |
|---|---|---|---|
| How often | Every two years (even years) | Every year | Every year |
| Window | 1 October – 31 December | 1 October – 31 December | Annual |
| FDA fee | None | Depends on product type | US$13,785 for FY 2027 |
| Submission | FDA Industry Systems (FURLS) | Electronic SPL files | FURLS Device Registration and Listing Module |
| US agent | Required for foreign facilities | Required, with DUNS | Required for foreign establishments |
Frequently asked questions
Is there a government fee for US FDA food facility registration?
No. The FDA charges no fee for food facility registration or its renewal. What you pay for is the work around it: obtaining a DUNS number, appointing a US agent (who charges separately) and filing correctly. Be careful of messages that ask you to pay the FDA for a food registration or a “certificate”. Medical device establishments are different and pay an annual FDA fee. We tell you upfront exactly which charges apply to you.
When must I renew my FDA food facility registration?
Between 1 October and 31 December of every even-numbered year. The current window runs from 1 October to 31 December 2026, and the FDA will treat any food facility registration not renewed by 31 December 2026 as expired. Renewal is done online in the FDA Industry Systems account and needs a valid Unique Facility Identifier. Renewing in October or November leaves time to fix a DUNS or agent mismatch. We send reminders well before the window closes.
What is a US agent and why do I need one?
A US agent is a person or company that lives in or keeps a place of business in the United States and is physically present there. Every foreign food facility must name one, with name, address, phone and email. The FDA contacts the agent to confirm the appointment before it confirms your registration. A mailbox or answering service is not enough. We coordinate with a US agent of your choice and make sure the details match exactly.
What is a DUNS number and is it compulsory?
A DUNS number is a nine-digit identifier issued by Dun & Bradstreet. The FDA currently accepts it as the Unique Facility Identifier required for food facility registration and renewal. For drug establishments, the DUNS number must belong to the specific facility, not the head office. A mismatch between the DUNS record and your registration address is a common reason for delay. We help you get it right before filing.
Does FDA registration mean my product is FDA approved?
No. Registration only tells the FDA about your facility. It is not an approval of your product or a certificate of quality. Some products, such as certain drugs and devices, need separate FDA clearance or approval before sale in the US. Food facilities also agree, when registering, that the FDA may inspect them. Do not print “FDA approved” on a label or brochure on the strength of registration alone. We help you describe your status accurately.
My unit only stores and packs spices. Do I still register?
Yes, if the food goes to the US. The rule covers facilities that manufacture, process, pack or hold food, so packing and storage sites count. The exemption applies only where another facility outside the US processes or packs the food further before it is exported, and that later step is more than minor. Each site that qualifies needs its own registration. We map your sites and tell you which ones must register.
What changes must be reported to the FDA?
Any change in the information in your food facility registration, such as a new US agent, a new owner or new product categories, must be updated within 60 days. If the facility closes or changes ownership, the registration must be cancelled within 60 days. Not updating or cancelling is itself a prohibited act under US law. We handle updates as soon as you tell us something has changed.
Do I also need Indian registrations to export to the US?
Yes. To export from India you need an Import Export Code from DGFT, and many exporters also take membership of the relevant export promotion council or commodity board. Food exporters often register with APEDA, and drug exporters need a valid Indian manufacturing licence. US FDA registration sits on top of these, not in place of them. We can arrange the Indian side and the FDA side together.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
FDA fees: food facility registration and renewal, nil. Medical device annual establishment registration, US$13,785 for FY 2027 (1 October 2026 to 30 September 2027). The US agent’s own charges are separate.
Ready to begin?
Share your product list and facility address, and we will get your FDA registration or 2026 renewal filed before 31 December.