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.
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.
How the Process Works
A streamlined process that gets your registration filed quickly and accurately.
Send Your Details
Complete the form for your registration type. A reference number is emailed to you straight away.
Review & Quote
A consultant confirms the scope, which FDA fees apply, and our service fee before anything is filed.
FDA Submission
We prepare and submit your registration or listing, and handle any FDA queries that follow.
Registration Confirmed
Your registration number is issued, along with an LMG certificate your buyers can verify online.
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.
Frequently Asked Questions
How long does registration take?
Do I need a U.S. Agent?
What is a DUNS number and do I need one?
When do I have to renew?
I make more than one type of product. What then?
Can you fix a registration someone else filed incorrectly?
Prefer to ask before you file?
Message the desk that handles your product type. We answer during U.S. business hours.
Office: +1 630 270 2921 · Send a message