The US FDA registration database is a critical compliance tool for companies involved in drugs, medical devices, cosmetics, and food products intended for the United States market. Maintained by the U.S. Food and Drug Administration, this database allows regulators, import authorities, and businesses to verify whether an establishment or product is properly registered under US law.
Understanding how this database works is essential for manufacturers, exporters, and brand owners—especially those operating outside the United States.
What Is the US FDA Registration Database?
The US FDA registration database is an official electronic system that stores registration and listing details submitted by regulated establishments. Depending on the product category, companies are required to register their facilities and, in many cases, list the products they manufacture or distribute.
This system helps the US FDA monitor compliance, conduct inspections, issue FEI numbers, and track regulated activities across global supply chains.
Why FDA Registration Matters
FDA registration is not optional for most regulated products entering the US market. Without proper registration:
- Shipments may be detained or refused at US ports
- Products can be flagged during customs clearance
- Companies may face warning letters or enforcement actions
The FDA registration database serves as the first checkpoint for verifying regulatory legitimacy.
Key Components Inside the FDA Registration Database
The database includes several interconnected systems, each serving a specific regulatory purpose:
Establishment Registration
Manufacturing, processing, packing, or holding facilities must register annually. This applies to drug manufacturers, medical device producers, and other regulated entities.
Product Listing Information
For drugs and devices, companies must list products linked to a registered establishment. This listing does not mean “approval,” but it confirms regulatory disclosure.
FDA Establishment Identifier (FEI)
Once registered, a facility is assigned an FEI number. This unique identifier is used during inspections, audits, and regulatory correspondence.
Medical Device Registration Records
Medical device companies are listed in a separate FDA registration database specific to devices, including manufacturer and product classification data.
How to Check US FDA Registration Details
Many parts of the FDA registration database are publicly accessible. Businesses commonly use it to:
- Verify an FDA registration number
- Confirm an establishment’s FEI number
- Check whether a facility is currently registered
- Validate medical device registration details
However, not all product-level data is public, and approval status must be checked through separate FDA systems.
Is FDA Registration the Same as FDA Approval?
This is one of the most common misunderstandings.
FDA registration simply confirms that a facility and/or product has been disclosed to the FDA. FDA approval, on the other hand, involves scientific review and authorization—primarily for drugs, biologics, and certain medical devices.
For drugs, approval status is typically verified through the FDA’s drug approval records, including reference systems such as the Orange Book, which is free to access.
Cost of FDA Registration
FDA registration fees vary depending on product category:
- Drug establishments must pay an annual FDA facility fee
- Medical device registration includes an annual establishment fee
- Some categories, such as cosmetics, do not currently have FDA registration fees
The exact cost depends on regulatory classification and business size.
Common Compliance Challenges
Companies often face issues such as incorrect listings, expired registrations, mismatched FEI data, or misunderstanding approval versus registration requirements. These errors can delay market entry or trigger regulatory scrutiny.
This is where expert guidance becomes valuable.
How XPRO America Can Help
XPRO America is a US FDA Consultancy specializing in FDA registration, database verification, and compliance strategy for global companies. From initial establishment registration to FEI number support and medical device database listings, our team ensures accuracy and regulatory alignment at every stage.
If you need professional assistance navigating FDA registration systems or verifying database records, reach out to our compliance team at support@xproamerica.com for tailored guidance.
Final Thoughts
The US FDA registration database is more than a regulatory formality it is a foundational requirement for legal market access in the United States. Understanding how it works, what it shows, and what it does not show can save businesses time, money, and compliance risk.
With the right knowledge and the right FDA consultancy partner FDA registration becomes a manageable and strategic process rather than a regulatory obstacle.
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