FDA Registration
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, medical devices, or cosmetic products in the USA.
FDA Registration Services for Food, Drug, Device, and Cosmetic Establishments
FDA registration is a basic legal requirement for both domestic and foreign establishments that manufacture, process, pack, or market food, dietary supplements, drugs, active pharmaceutical ingredients (APIs), medical devices, or cosmetic products in the United States. Registering notifies the FDA that your establishment exists — a prerequisite for legally placing your products on the U.S. market.
Requirements differ by product type, so this page gives an overview of FDA registration and links to detailed guidance for each category. Whether you are a first-time registrant or maintaining an existing registration, Liberty Management Group (LMG) can complete the process on your behalf.
What FDA Registration Is — and Is Not
It is important to understand what registration means. Registration tells the FDA who you are and where you operate; it does not mean the FDA has reviewed, approved, certified, or endorsed your establishment or your products. Under FDA rules, presenting a registration number as evidence of FDA approval is misleading and can constitute misbranding. After we complete your registration, LMG issues a free registration certificate for your own records — a confirmation of the work performed, not an FDA endorsement.
U.S. FDA Agent: A Mandatory Requirement for Foreign Establishments
Every foreign establishment must designate a U.S. FDA Agent as part of registration. This is not optional — registration cannot be completed without a U.S. Agent, and the FDA will contact the agent to confirm the appointment. The U.S. Agent serves as the establishment’s point of communication with the FDA. LMG can act as your U.S. FDA Agent, ensuring this requirement is met quickly and correctly.
Why Register with LMG?
- Experienced handling of food, drug, API, medical device, and cosmetic registrations
- U.S. FDA Agent services for foreign establishments
- Fast, accurate submissions through FDA systems
- A free registration certificate for your records upon completion
Ready to register or have questions about which requirements apply to you? Contact LMG today and we will guide you through the right FDA registration process for your products.
Choose Your FDA Registration Type
Select the category that matches your products for specific requirements, renewal cycles, and how to register:
Drug Establishment Registration
Establishments that manufacture or process drugs and APIs for the U.S. market must register and list their products, with annual renewal. Learn more about Drug Establishment Registration.
Learn More
Medical Device Registration
Manufacturers and other establishments handling medical devices for U.S. distribution must register, list their devices, and meet annual requirements. Learn more about Medical Device Registration.
Learn More
Food Facility Registration
Domestic and foreign facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA and renew on a biennial cycle. Learn more about Food Facility Registration.
Learn More
Cosmetic Facility Registration
Under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic manufacturers and processors must register their facilities and list their cosmetic products. Learn more about Cosmetic Facility Registration.
Learn More
US FDA Agent Service
Every foreign establishment must appoint a U.S. FDA Agent to complete registration. LMG serves as your U.S. Agent and handles all communications with the FDA. Learn more about the U.S. FDA Agent Service.
Learn More
Free Registration Certificate
Once your registration is complete, LMG issues a free certificate for your records. It is a private confirmation of the filing, not an FDA approval or endorsement. Learn more about the Registration Certificate.
Learn More
Frequently Asked Questions
Who needs to register with the FDA?
Domestic and foreign establishments that manufacture, process, pack, or market food, drugs, APIs, medical devices, or cosmetics for the U.S. market generally must register. The specific requirements depend on the product type.
Does FDA registration mean my product is FDA approved?
No. Registration is a notification to the FDA, not an approval, certification, or endorsement of your establishment or products. Claiming otherwise can be considered misbranding.
Do foreign companies need a U.S. Agent to register?
Yes. A U.S. FDA Agent is mandatory for all foreign establishments, and registration cannot be completed without one.
Does the FDA issue a registration certificate?
No. The FDA does not issue registration certificates. LMG provides its own certificate confirming your registration for your records, which should not be represented as an FDA document.
Ready to Register with FDA?
LMG handles all FDA registration types.
Start FDA Registration Contact Us