A DUN’S number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B), a business credit bureau. The DUNS Number is location specific. So, each physical location of an entity such as branches, divisions, and headquarters may be assigned a DUN’S number separately.
To market food, drugs and medical devices products in the United States, companies must have DUNS number.
Food: All domestic and foreign food facilities what wants to sell their food products in the US will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. DUNS number is the only acceptable UFI recognized by FDA.
For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.
For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.
Drugs: US FDA will directly pull the company information only from FDA’s DUNS portal. So, companies who want to register with FDA must obtain DUNS first and then proceed with registration.
Medical Devices: Even though for now, DUNS number is not mandatory to register, to submit Unique Device Identification (UDI), DUNS is a mandatory requirement.
DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUN’S number first. DUNS requests may take up to 30 days.
Liberty Management Group, as leading FDA consultant provide assistance with DUNS number lookup and FDA registration and renewals.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us