When medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device Identification requirements, one of the prerequisite steps for all manufacturers is to establish a Global Unique Device Identification Database account....
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What Your CEO Needs to Know about UDI
Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with the FDA’s final rule on Unique Device Identification (UDI) takes time and planning. But convincing the executives in the C-suite to allot the necessary...
UDI Data Submission: Who is Responsible?
As part of the FDA’s Unique Device Identification (UDI) mandate, medical device labelers are required to submit a data record for the devices they market in the United States to the FDA’s Global Unique Device Identifier Database (GUDID). But who does the FDA consider...
One Step in FDA UDI Compliance: The Dun & Bradstreet DUNS Number
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...