US Agent Wizard
A step-by-step educational guide to FDA US Agent requirements. Learn who needs one, what they do, how to choose the right agent, and how the designation process works.
Do I Need a US Agent?
Who Needs a US Agent?
Under FDA regulations, any foreign establishment that manufactures, processes, packs, or holds food, drugs, devices, or cosmetics for import into the United States must designate a US Agent.
- Foreign food facilities (21 CFR 1.227)
- Foreign drug establishments (21 CFR 207)
- Foreign medical device establishments (21 CFR 807)
- Foreign cosmetics facilities (MoCRA, effective July 2024)
- Foreign tobacco product manufacturers
Exceptions
US-based companies that manufacture entirely within the US do not need a US Agent. However, if any part of the supply chain involves a foreign facility, that facility needs its own US Agent.
Tip: If your products are manufactured outside the US and sold in the US market, you almost certainly need a US Agent.
Disclaimer: This educational wizard provides general information about FDA US Agent requirements. Specific requirements may vary based on your product type and circumstances. This tool does not constitute regulatory or legal advice. Always verify current requirements at FDA.gov.
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