In preparing for compliance with the U.S. Food and Drug Administration’s final rule requiring Unique Device Identifiers (UDIs) for medical devices distributed in the U.S., there are a number of steps that device manufacturers should be aware of before submitting data to the GUDID—the Global Unique Device Identification Database.
One of those steps has the potential to cause some delay for unaware device manufacturers.
In order to submit UDI information to the FDA’s Electronic Submissions Gateway (ESG), each manufacturer must be identified with its own D-U-N-S® Number. A DUNS (Data Universal Numbering System) Number is a unique nine-digit number used to track businesses. Recognized as the worldwide standard in business identification, a DUNS Number allows potential customers and suppliers to learn more about a company through centralized information collected by Dun & Bradstreet, one of the leading sources of businesses and commercial information.
For medical device companies that already have a Dun & Bradstreet Number, this will most likely be a quick step in the GUDID collection and submission process for your ESG account. Just make sure all your information is up-to-date (see Step 1.B. in the Steps to Comply graphic for more information).
If your company does not have a DUNS Number, you can obtain one free of charge from D&B. Is it complicated? No, but acquiring a DUNS Number for medical device manufacturers represents an additional step in the process for medical device manufacturers, many of whom are just beginning to research their UDI submissions options. Access the D&B DUNS website at http://www.dnb.com/get-a-duns-number.html and fill in your business information—the name of your organization, its location, principal or owner name, legal structure, formation date, nature of your business, etc.
While applying for a DUNS Number is free, the entire process may take up to 30 business days to complete unless you pay for an expedited option.
International medical device manufacturers who ship to the U.S. must also comply with the FDA UDI ruling, and therefore must also request a DUNS Number in preparation to submit to the GUDID. Please check with a D&B customer service center in your country of origin for information specific to your application.
Manufacturers utilizing third-party submitters—like Reed Tech—will be required to identify their submitter’s DUNS Numbers before handing over the process.