U.S. Agent included
Filed within 1–2 business days
Certificate you can verify
Start Your FDA Registration
Most food, drug, medical device and cosmetic products must be registered or listed with the U.S. FDA before they can be imported or marketed. Tell us what you make — we prepare the filing, act as your U.S. Agent, and hand you the confirmation number.
What do you make?
Pick a category to see the registrations that apply to it. If you handle more than one product type, you'll need a filing under each — we can bundle them.
Food Facility Registration
Required for every facility that manufactures, processes, packs or holds food for U.S. consumption. Renews in even-numbered years.U.S. Agent Service
Every foreign facility must name a U.S. Agent as FDA's point of contact. We act as yours and forward all FDA correspondence.Prior Notice
Filed for each shipment of imported food before it arrives at the U.S. port. We can file per shipment or on standing instructions.LACF / Acidified Foods
Low-acid canned and acidified food processors need a separate FCE number and scheduled process filings on top of facility registration.Drug Establishment Registration & NDC Labeler Code
Registers your establishment with FDA and obtains the NDC labeler code you need before any product can be listed.Drug Product Listing (SPL)
Each product, package size and label is listed with FDA in SPL format. We prepare and submit the SPL file and handle updates.U.S. Agent Service
Mandatory for foreign drug establishments. We are named in your registration and receive FDA communications on your behalf.Label Review
We check your label against FDA's drug labeling requirements before you print — cheaper than a detention at the port.Device Establishment Registration & Listing
Annual registration in FURLS/DRLM, plus a listing for every device you manufacture, specification-develop, repack or relabel.UDI / GUDID Submission
Device identifiers published to FDA's GUDID database. We prepare the record set and manage the submission through to publication.U.S. Agent Service
Required for every foreign device establishment, and named at the time of registration.Not sure of your device class?
Class drives the fee, the listing and whether a 510(k) is needed. Run the classification tool before you file.Cosmetic Facility Registration (MoCRA)
Facilities that manufacture or process cosmetics for the U.S. market must register and renew every two years under MoCRA.Cosmetic Product Listing
Every marketed cosmetic product needs a listing with its ingredient statement and product category code.U.S. Agent Service
Foreign cosmetic facilities must name a U.S. Agent in the MoCRA registration.Product Category Code Builder
MoCRA listings require FDA's category code for each product. Build yours before you fill in the listing form.Not ready to file yet?
Find out what applies to you first
Our compliance tools are free and take a couple of minutes. Use them to confirm what you need before you send us anything.All compliance tools13 free tools in one place
FDA fee estimatorEstimate your government fees
Device classificationFind your class and product code
Food registration navigatorCheck if your facility must register
Cosmetic MoCRA navigatorRegistration and listing obligations
NDC validatorCheck an NDC code format
How the Process Works
A streamlined process that gets your registration filed quickly and accurately.
1
Send Your Details
Complete the form for your registration type. A reference number is emailed to you straight away.2
Review & Quote
A consultant confirms the scope, which FDA fees apply, and our service fee before anything is filed.3
FDA Submission
We prepare and submit your registration or listing, and handle any FDA queries that follow.4
Registration Confirmed
Your registration number is issued, along with an LMG certificate your buyers can verify online.What's included
Every registration comes with
- U.S. Agent representation for the full registration period
- DUNS number guidance if you don't already have one
- Preparation and submission of the FDA filing
- Handling of FDA correspondence and follow-up queries
- Renewal reminders ahead of every deadline
- An LMG certificate with online verification
About the fees
Two separate things are often confused. FDA user fees are set by FDA each fiscal year and paid to the U.S. Treasury — for example the annual device establishment fee and the OMUFA facility fee for OTC drugs. LMG service fees cover our preparation, filing and U.S. Agent work. Food facility registration and cosmetic facility registration carry no FDA user fee.Before you file
Frequently Asked Questions
How long does registration take?
Once we have complete information, most registrations are submitted within one to two business days. FDA's own processing time varies by programme — food facility registrations are typically confirmed immediately, while device listings and NDC labeler code requests can take longer.
Do I need a U.S. Agent?
Yes, if your facility is outside the United States. FDA requires a U.S. Agent as its point of contact for every foreign food, drug, device and cosmetic facility. The agent must have a physical U.S. address and be reachable during business hours. We provide this as part of our service.
What is a DUNS number and do I need one?
A DUNS number is a nine-digit business identifier issued by Dun & Bradstreet, and FDA uses it to verify facility identity. It's free to obtain and required for most registrations. If you don't have one, tell us on the form and we'll guide you through the request.
When do I have to renew?
Food and cosmetic facility registrations renew every two years. Device establishment registration renews annually. Drug establishment registration and product listings must be reviewed and confirmed each year. We track your dates and remind you in advance.
I make more than one type of product. What then?
Each product category has its own registration programme, so a facility making both cosmetics and OTC drugs needs a filing under each. Send us the details and we'll map out what applies and quote for the set.
Can you fix a registration someone else filed incorrectly?
Yes. We regularly correct registrations with wrong establishment types, missing listings or lapsed U.S. Agent details. Send us your existing registration number and we'll review it.
Talk to us first
Prefer to ask before you file?
Message the desk that handles your product type. We answer during U.S. business hours.Food & Beverage
WhatsApp +1 331 465 4972
Facility registration, prior notice, LACF
Drugs & Medical Devices
WhatsApp +1 331 218 8946
Establishment registration, listing, UDI
Cosmetics
WhatsApp +1 630 864 9023
MoCRA registration and product listing
Office: +1 630 270 2921  · Send a message