Medical Device DUNS Request Assistance

A DUNS Number is a unique 9-digit identifier assigned by Dun & Bradstreet (D&B). FDA's Center for Devices and Radiological Health uses DUNS data in device systems to standardize company names and physical addresses and improve entity identification.

FDA's current Device Registration and Listing Module collects DUNS information and uses D&B validation for domestic facility and address data, but FDA's current registration instructions do not present DUNS as a universal statutory requirement for every facility under 21 CFR Part 807. DUNS is also used in other CDRH workflows, including GUDID and certain medical-device user-fee account processes. We review the specific workflow before determining what your facility needs.

FDA uses DUNS information to help identify and standardize business entities and physical locations. CDRH states that DUNS numbering is implemented in Registration and Listing and GUDID, and the Device Registration and Listing Module validates domestic facility name/address and DUNS combinations against D&B data.

No. A DUNS Number is assigned by Dun & Bradstreet. An FEI is an FDA Establishment Identifier used by FDA to identify establishments in agency systems. They are different identifiers and one does not replace the other.

DUNS numbers are location-specific identifiers. Separate physical business locations can have separate DUNS records, so the number used for an FDA workflow should correspond to the correct facility or organization record rather than an unrelated headquarters location.

Yes. FDA's DRLM instructions explain that domestic facility name, address, and DUNS information are validated against D&B data. If a DUNS entered into the system does not exist in the D&B database, it must be corrected before proceeding. Name or address mismatches can also create avoidable validation issues.

Timing is controlled by Dun & Bradstreet and varies by request. FDA's current GUDID preparation guidance notes that obtaining a DUNS Number can take up to 30 business days and that expedited options may be available from D&B. Our service focuses on preparing accurate information, checking the appropriate location record, and following the request through verification.

FDA does not charge a government fee to issue a DUNS Number because DUNS numbers are assigned by Dun & Bradstreet, not FDA. D&B offers a standard DUNS request process, and expedited options may involve separate D&B charges. FDA Registration Assistance charges a one-time professional service fee of $399 for our request and verification assistance.

Yes. A company can work directly with Dun & Bradstreet. Our service is for businesses that want help selecting the correct facility record, preparing consistent legal name and address information, resolving validation issues, and coordinating the DUNS information with the applicable FDA device workflow.

We typically need the legal business or facility name, physical address, business contact information, country, business activity, and any existing D&B, FDA, FEI, FURLS/DRLM, or GUDID information that may help us identify the correct record and avoid duplicates.

A DUNS Number is not an annual FDA registration and does not renew on the FDA's October-December cycle. However, the underlying D&B business record should remain accurate, and any FDA registration, listing, GUDID, or user-fee records that use the DUNS information should also be kept current.

Update the underlying Dun & Bradstreet record and then update any FDA systems that rely on that information. Whether a relocation or restructuring requires a different DUNS record depends on the facts and D&B's entity/location rules, so we verify the correct record before making FDA updates.

Yes. DUNS is used in several FDA medical-device workflows for foreign companies. For example, FDA's MDUFA user-fee system requires a DUNS Number for foreign firms creating the applicable user-fee account, and FDA's GUDID preparation guidance instructs labelers to identify or obtain appropriate DUNS numbers.

FDA's GUDID program uses DUNS information to identify the labeler organization and standardize company data. FDA recommends confirming that the correct DUNS record exists and that the D&B information is accurate before creating or maintaining GUDID records.

Yes. We can coordinate the DUNS request or verification with the related FDA medical-device workflow so the business name, physical location, and identifier information are consistent before registration, listing, GUDID, or applicable user-fee steps are completed.

Submit the contact form with your facility name, physical address, country, and a short description of the FDA device activity you are preparing for. We will review the information, identify the appropriate DUNS workflow, and advise what is needed before proceeding.