This article was checked in September 2026. Rules and figures change, so confirm them before you act. We are not lawyers or tax advisers.
The short answer
| Question | Answer |
|---|---|
| Who must register with the FDA? | Food facilities and medical device makers that sell to the US. |
| When do food registrations renew? | Every even-numbered year, from October to December. 2026 is a renewal year. |
| Do I need a US agent? | Yes. Foreign facilities must name a US agent. |
| Do food samples need prior notice? | Yes. Food shipments, including samples, need FDA prior notice. |
Key takeaways
- Register before you ship, not after a hold.
- Renew food registrations between October and December 2026.
- Test spices and nuts for Salmonella, aflatoxin and lead.
- Keep your US agent details current.
Which products need FDA registration?
- Food: rice, spices, dry fruits, salt, snacks, sauces and other foods and drinks
- Medical devices: surgical, dental and many other medical instruments
- Cosmetics: US rules also require registration of cosmetic facilities and product listings
Leather, textiles, furniture and most sports goods are not FDA regulated.
Food exporters
Food facility registration
Any foreign facility that makes, processes, packs or holds food for the US must register with the FDA. There is no FDA fee for food facility registration. Registrations must be renewed every even year between October 1 and December 31, so 2026 is a renewal year.
US agent
Foreign food facilities must name a US agent, a person or company in the US that the FDA can contact. The agent must agree to it in writing.
Prior notice
The FDA must be told about every food shipment before it arrives in the US. Your importer, broker or agent usually files this.
Foreign supplier checks
The US importer must check that its foreign suppliers meet US food safety rules. Expect buyers to ask for your food safety plan and lab tests.
Medical device exporters
Registration and listing
Factories that make medical devices for the US must register with the FDA every year and list each device type. There is a yearly FDA establishment registration fee, which the FDA sets each year.
US agent
Foreign device makers must also name a US agent.
Clearance
Most basic surgical and dental instruments are Class I devices. Many Class I devices do not need premarket clearance, but they still must follow FDA quality system rules. Since February 2026, those rules line up closely with the ISO 13485 standard.
How we help
We are not an FDA consultant and do not act as your FDA agent by default. We coordinate licensed FDA consultants and US agents for our clients and build their costs into your plan.
Food and medical devices compared
| Food, spices, rice, nuts | Surgical and dental instruments | |
|---|---|---|
| Registration | Facility registration, renewed every even-numbered year | Establishment registration every year, with a yearly fee |
| US agent | Required | Required |
| Before each shipment | Prior notice | Device listing in place |
| Buyer's duty | Importer verifies you as a supplier | Importer checks registration and listing |
Why shipments get held
- Missing or expired registration
- No prior notice for food
- Test results showing Salmonella, aflatoxin or lead in spices
- Labels that do not meet FDA rules
Want us to handle this for you?
We are a US office in Chicago for Pakistani exporters. We set up your US company, build your website and find US buyers. You sell to them directly.
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Rules and shippingUS labeling rules
Getting startedExport to USA from Pakistan
Common questions
Does rice exported from Pakistan need FDA registration?
Yes. The facility that mills or packs the rice must be registered with the FDA, have a US agent, and send prior notice for each shipment.
Is there a fee for FDA food facility registration?
No. The FDA does not charge for food facility registration. Consultants and US agents charge for their services.
Do surgical instruments from Pakistan need FDA registration?
Yes. The factory must register with the FDA, list its devices, pay the yearly fee and name a US agent.
Does Himalayan salt need FDA registration?
Food-grade salt does. The facility that packs it must be registered and each shipment needs prior notice. Salt lamps and decor are not food.
Do you register us with the FDA?
We coordinate licensed FDA consultants and US agents, and quote their cost up front.