What Is a U.S. FDA Registration Number?
A U.S. FDA Registration Number is a unique identifier assigned by the U.S. Food and Drug Administration to a facility or establishment that is required to register with the FDA. It confirms that a company has completed the mandatory FDA establishment registration process under applicable U.S. regulations.
Importantly, the FDA does not issue one single type of registration number for all products. The identifier you receive depends on the regulatory framework applicable to your business.
Common Types of FDA Registration Numbers
Understanding the difference between FDA identifiers is essential to avoid compliance mistakes.
FDA Establishment Registration Number
This number is assigned to facilities involved in manufacturing, processing, packing, or holding FDA-regulated products. It applies to drug manufacturers, medical device facilities, food facilities, and cosmetic manufacturers.
FDA Establishment Identifier (FEI)
The FEI number is a unique numeric identifier assigned by the FDA to track inspections and compliance history. It is commonly requested during inspections, regulatory correspondence, and official submissions.
Device Registration and Listing Numbers
Medical device companies receive establishment registration confirmation along with product listing details. The registration itself does not mean device approval.
Food Facility Registration Number
Food manufacturers and exporters must register their facilities under the FDA Food Safety Modernization Act (FSMA). This registration is mandatory before shipping food products to the U.S.
Each of these numbers serves a regulatory tracking purpose, not a marketing or quality certification role.
Is an FDA Registration Number the Same as FDA Approval?
No. This is one of the most critical points for compliance.
An FDA Registration Number does not equal FDA approval.
- Registration means the facility is listed with the FDA
- Approval applies only to specific products such as drugs, biologics, or certain medical devices
- Most FDA-regulated products enter the U.S. market without “approval” but still require registration
Using the term “FDA approved” incorrectly can result in warning letters, product detention, or import refusal.
Who Needs a U.S. FDA Registration Number?
You need an FDA registration number if your business falls into any of the following categories:
- Drug manufacturers and repackers
- Active Pharmaceutical Ingredient (API) manufacturers
- Medical device manufacturers and contract manufacturers
- Food and beverage manufacturers
- Dietary supplement manufacturers
- Cosmetic manufacturers
- Foreign companies exporting FDA-regulated products to the U.S.
Foreign companies must also appoint a U.S. FDA Agent as part of the registration process.
When Is FDA Registration Mandatory?
FDA registration is required before:
- Exporting products to the United States
- Shipping samples for commercial distribution
- Listing products with U.S. distributors
- Facing FDA inspections or customs clearance
For most product categories, registration must also be renewed annually. Failure to renew can cause automatic cancellation of the registration number.
How to Obtain a U.S. FDA Registration Number
The registration process differs slightly by product category, but the general steps remain consistent.
Step 1: Identify Product Classification
Determine whether your product is regulated as a drug, device, food, cosmetic, or supplement.
Step 2: Appoint a U.S. FDA Agent (for Foreign Companies)
Non-U.S. manufacturers must designate a U.S. Agent responsible for FDA communication.
Step 3: Prepare Facility Information
This includes legal entity name, physical address, operational activities, and contact details.
Step 4: Complete FDA Online Registration
Registration is submitted through FDA electronic systems specific to each product category.
Step 5: Receive Confirmation
Once accepted, the FDA assigns the establishment registration confirmation and relevant identifiers such as the FEI number.
Many companies choose professional assistance to avoid delays, data mismatches, or rejection due to incomplete submissions.
How to Check or Verify an FDA Registration Number
FDA registration status can be verified using public FDA databases depending on the product type.
- Drug establishment registrations can be searched in FDA drug databases
- Medical device establishments are searchable through FDA device listings
- Food facility registration status may require importer verification
It is important to note that not all FDA registration numbers are publicly visible, especially for security and compliance reasons.
Common Mistakes Companies Make
Despite its importance, FDA registration is often handled incorrectly. Common errors include:
- Assuming FDA registration equals product approval
- Using expired or cancelled registration numbers
- Registering under the wrong product category
- Providing incorrect facility addresses
- Failing to renew registration annually
- Not appointing a compliant U.S. FDA Agent
Any of these mistakes can trigger FDA enforcement actions or import refusal.
FDA Registration Number for Indian Manufacturers
Indian pharmaceutical, medical device, food, and cosmetic companies exporting to the U.S. must comply fully with FDA registration requirements. The FDA treats foreign manufacturers with the same compliance expectations as U.S. facilities.
Indian companies are frequently inspected, and incorrect registration information is one of the most common reasons for FDA observations.
Role of an US FDA Consultancy in Registration
FDA registration may look straightforward, but regulatory interpretation, correct classification, and long-term compliance require expertise.
XPRO America, a professional US FDA Consultancy, supports global manufacturers with end-to-end FDA registration services, including establishment registration, U.S. Agent appointment, product listing, and compliance guidance across drugs, medical devices, food, and cosmetics.
For businesses seeking structured regulatory support, expert consultation can significantly reduce compliance risk. You can reach the XPRO America regulatory team directly at support@xproamerica.com for tailored FDA registration assistance.
Why FDA Registration Numbers Matter for Compliance
An active and accurate FDA registration number ensures:
- Smooth U.S. customs clearance
- Eligibility for FDA inspections
- Legal market entry into the United States
- Reduced risk of import alerts and warning letters
- Long-term regulatory credibility
Without proper registration, even high-quality products can be blocked from the U.S. market.
Final Perspective
A U.S. FDA Registration Number is not just a formality. It is a foundational compliance requirement that connects your facility to the FDA’s regulatory oversight system. Understanding what the number represents, how it differs from approval, and how to maintain it correctly is essential for any company targeting the U.S. market.
With proper registration strategy, accurate data submission, and ongoing compliance management, companies can confidently expand into the U.S. while minimizing regulatory risk.
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