DUNS Number vs FEI Number: What They Are and When You Need Each

What Is a DUNS Number?

The Data Universal Numbering System (DUNS) number is a unique nine-digit identifier for businesses, developed and managed by Dun & Bradstreet (D&B). It is widely used across government agencies, including FDA, to uniquely identify business entities.

In the FDA context, DUNS numbers are used in several key areas:

• Drug establishment registration: The DRLS system uses DUNS numbers to identify drug establishments (21 CFR Part 207)
• Device establishment registration: FURLS uses DUNS numbers for device establishment identification (21 CFR Part 807)
• FSVP importer identification: Under 21 CFR §1.509, the FSVP importer must provide their DUNS number at entry to identify themselves as the responsible party
• GDUFA (Generic Drug User Fee): Generic drug facilities use DUNS numbers for fee assessments

You can obtain a DUNS number for free from Dun & Bradstreet through their website. Processing typically takes 1–2 business days for the standard (free) request.

What Is an FEI Number?

The FDA Establishment Identifier (FEI) is a unique number assigned by FDA to each facility that registers with the agency. Unlike the DUNS number (which you obtain from a third party), the FEI is automatically generated by FDA when your registration is processed.

FEI numbers are used to:

• Identify your facility across all FDA systems (registration, inspection, compliance actions)
• Track inspection history and compliance status
• Link your facility to import entries, Prior Notice filings, and product listings
• Reference your facility in FDA warning letters, Import Alerts, and other enforcement documents

Your FEI number remains the same for the life of your facility. It does not change with registration renewals and is associated with the physical location, not the business entity.

Key Differences

Which Registrations Require Which?

• Food facility registration: FEI is assigned upon registration. DUNS number is not required for food facility registration but is needed if you are an FSVP importer.
• Drug establishment registration: Both DUNS and FEI are used. You need a DUNS number to register in DRLS, and FDA assigns the FEI.
• Device establishment registration: Both DUNS and FEI are used. FURLS requires your DUNS number during registration.
• Cosmetics (MoCRA): FEI is assigned during Cosmetics Direct registration. DUNS is not currently required for MoCRA registration.

If you are unsure whether you need a DUNS number for your specific registration, contact Assurentry for guidance. Our team handles registrations across all product categories and can advise on the specific identifiers you need.