A DUNS Number (Data Universal Numbering System Number) is a unique 9-digit identifier for businesses, issued by Dun & Bradstreet (D&B). It helps verify a company’s identity and establish a business credit file.
A valid DUNS Number is required for FDA registration. The DUNS number serves as a unique facility identifier (UFI), helping the FDA verify business locations and prevent duplicate or fraudulent entries.
Different types of registrations in FDA:
- The Food Safety Modernization Act (FSMA) requires domestic and foreign food facilities to provide a valid DUNS number when registering or renewing their registration with the FDA. This includes facilities that manufacture, process, pack, or hold food for consumption in the U.S.
2. Drug Establishment Registration
- For domestic and foreign drug establishments, the FDA requires a DUNS number when registering an establishment or when creating a user fee account to make OMUFA, PDUFA & GDUFA payments.
3. Medical Devices Establishment Registration
- A DUNS number is typically needed for foreign establishments registering their medical devices with the FDA and for creating user fee account to make MDUFA payments to FDA.
Liberty Management Group Ltd can help look up if a facility has a DUNS number or guide to obtain a new DUNS number along with FDA registration.
Namrata
Regulatory Consultant
support@libertymanagement.us