United States

Frequently Asked Questions

Which FDA registration does my product need?

It depends on your product group. Food and dietary supplements need facility registration (21 CFR Part 1, Subpart H), cosmetics need facility registration and product listing (FDA: cosmetic registration and listing), drugs need establishment registration and drug listing (21 CFR Part 207), and medical devices need establishment registration and device listing (21 CFR Part 807). Starter packages: food, cosmetics, drugs, medical devices.

Does FDA registration mean my product is FDA approved?

No. FDA does not issue a certificate for registration; it assigns your facility a registration number. Registration and listing do not mean that FDA has approved the facility or the product, and presenting them as approval counts as misbranding (for drugs 21 CFR 207.77, for medical devices 21 CFR 807.39). Do not use the phrase “FDA approved” on packaging or in marketing.

What is a US Agent, and do I need to find one separately?

A US Agent is the representative located in the United States through whom FDA reaches a foreign facility. Foreign food (21 CFR 1.227), cosmetic (FDA MoCRA registration guidance), drug (21 CFR 207.69) and medical device (21 CFR 807.40) facilities must designate a US Agent. In our facility registration packages we are designated as your US Agent, so you do not need to find one separately.

After registration, is a separate step needed for each shipment?

For food, yes. Every food shipment entering the United States, samples included, must be notified to FDA before arrival (Prior Notice, 21 CFR Part 1, Subpart I). We file the notice on your behalf through our Prior Notice service.

Whose obligation is FSVP?

The US importer’s (21 CFR Part 1, Subpart L). As the exporter, you are usually asked for the documents your importer needs for its FSVP file. We prepare those documents with you and also help set up the FSVP structure on the importer’s side.

My product contains animal-origin raw materials. Is FDA registration enough?

Not always. Importing certain animal-origin raw materials that may carry animal diseases requires a USDA APHIS permit (USDA APHIS: Animal health permits). We review your product’s composition to see whether a permit is needed and, if so, prepare the VS 16-3 import permit together with your importer.