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 Domestic and Foreign 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.
Since 2009, Liberty Management Group (LMG) has assisted thousands of establishments in 150+ countries to complete FDA registration accurately and on time. We handle every FDA registration type — food, drug, medical device, and cosmetic — at a fixed, transparent price with no hidden fees. Every registration completed by LMG includes a free registration certificate for your records.
FDA Registration Requirements by Product Type
Requirements differ significantly by product category. Select your product type below for detailed requirements, renewal cycles, and how to register:
Drug Establishment Registration
Establishments that manufacture, repack, relabel, or salvage drug products or APIs for the U.S. market must register under 21 CFR Part 207 and list all marketed drug products. Registration must be renewed annually by December 31. Drug listings must be updated every June and December. Foreign drug establishments must designate a U.S. FDA Agent.
Learn more about Drug Establishment Registration
Medical Device Registration
Owners and operators of establishments involved in the production and distribution of medical devices for U.S. use must register annually and list their devices. Registration must be renewed annually during October 1 to December 31 and the annual FDA establishment registration fee must be paid. Foreign establishments must designate a U.S. FDA Agent.
Learn more about Medical Device Establishment Registration
Food Facility Registration
Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register under Section 415 of the FD&C Act, as amended by FSMA. Registration must be renewed biennially during October 1 to December 31 of each even-numbered year. There is no FDA fee for food facility registration. Foreign facilities must designate a U.S. FDA Agent.
Learn more about Food Facility Registration
Cosmetic Facility Registration
Under the Modernization of Cosmetics Regulation Act (MoCRA), establishments that manufacture or process cosmetic products for U.S. distribution must register their facilities and list all marketed cosmetic products. Registration must be renewed biennially, tied to the anniversary of the initial registration date. Foreign establishments must designate a U.S. FDA Agent.
Learn more about Cosmetic Facility Registration
US FDA Agent Service
Every foreign establishment must appoint a U.S. FDA Agent to complete registration. The U.S. Agent serves as the official point of communication between your facility and the FDA. Without a confirmed U.S. Agent, your registration cannot be completed or maintained. LMG serves as U.S. FDA Agent for food, drug, medical device, and cosmetic establishments in 150+ countries.
Learn more about US FDA Agent Service
Free Registration Certificate
After completing your registration, LMG issues a free certificate for your records at no extra charge. The FDA does not issue registration certificates, yet importers, buyers, Amazon sellers, and customs brokers routinely request proof of registration from suppliers. LMG's certificate serves as that proof and can be independently verified at fdahelp.us.
Learn more about the Registration Certificate
FDA Registration Renewal Summary
| Registration Type | Renewal Cycle | Renewal Window | FDA Fee |
|---|---|---|---|
| Food Facility | Biennial (every 2 years) | Oct 1 – Dec 31, even years | None |
| Drug Establishment | Annual | Oct 1 – Dec 31, every year | OTC Monograph Fees |
| Medical Device | Annual | Oct 1 – Dec 31, every year | Medical Device Establishment Registration Fees |
| Cosmetic Facility (MoCRA) | Biennial (every 2 years) | Anniversary of initial registration | None |
What FDA Registration Is — and Is Not
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 the FD&C Act, presenting a registration number as evidence of FDA approval is misleading and can constitute misbranding.
The FDA does not issue registration certificates. After completing your registration, LMG issues a free private certificate confirming the registration — a useful internal record and proof of registration for buyers, importers, and customs brokers. LMG certificates can be independently verified at fdahelp.us.
U.S. FDA Agent: Mandatory for All 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 one. The FDA contacts the U.S. Agent directly to confirm the appointment and uses the Agent as the official point of communication for all regulatory matters.
LMG provides U.S. FDA Agent services for food, drug, medical device, and cosmetic establishments worldwide. As your U.S. Agent, LMG handles all FDA communications, registration renewal reminders, and — for food facility clients — our complimentary LMG FDARegWatch  service proactively monitors your registration status and alerts you if a problem is detected.
Since 2009, LMG has completed over 15,000 FDA registration projects for clients in 150+ countries. Here is how we compare:
LMG vs. Other FDA Registration Services
| Service Feature | Other Consultants | LMG |
|---|---|---|
| Pricing | Hourly fees or undisclosed pricing | ✓ Fixed price, published on website |
| Price Stability | Fees increase regularly | ✓ No fee increases since 2009 |
| Track Record | Limited or unverified project history | ✓ 15,000+ projects completed since 2009 |
| Registration Certificate | Extra charge or not provided | ✓ Free with every registration |
| Certificate Verification | No independent verification | ✓ Verifiable online at fdahelp.us |
| Turnaround Time | Varies, often unpredictable | ✓ Most registrations within 1–5 business days |
| Countries Served | Limited regional coverage | ✓ 150+ countries worldwide |
| Registration Monitoring | Not included or paid add-on | ✓ Free LMG FDARegWatch for food clients |
| Import Detention Help | Referred to third parties | ✓ Specialist DWPE removal assistance |
| Proprietary Platforms | No proprietary tools | ✓ SPL Matrix™, eCTD Pro™, Compliance Monitor™ |
| Free Compliance Tools | Limited or subscription required | ✓ Full suite free, no account required |
| Experience | Varies widely | ✓ FDA regulatory specialists since 2009 |
Frequently Asked Questions About FDA Registration
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.
How long does FDA registration take?
Food facility registration is typically completed within 1 to 3 business days. Medical device and drug establishment registration are typically completed within 1 to 5 business days. LMG handles the entire process.
How much does FDA registration cost?
There is no FDA government fee for food facility or cosmetic facility registration. Medical device and OTC monograph drug registrations carry annual FDA fees. LMG service fees are published on the LMG fees page
When must FDA registration be renewed?
Food facility and cosmetic facility registrations renew biennially. Drug and medical device establishment registrations renew annually, from October 1 to December 31. Missing a renewal deadline can result in registration lapsing and products being considered misbranded.
Can one registration cover multiple locations?
No. FDA registration is site-specific. Each physical manufacturing location must register independently, regardless of common ownership, and receive its own FEI (FDA Establishment Identifier) number.
What happens if a foreign facility's registration lapses?
Products from foreign facilities with lapsed registrations will be refused entry at U.S. ports of entry. For food facilities in particular, there is no advance notice from the FDA when a registration lapses — which is why LMG provides complimentary FDARegWatch monitoring for food facility clients.
Ready to Register with FDA?
LMG handles all FDA registration types.
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