GUDIDGlobal Unique Device Identification Database (US FDA)
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The FDA will not enforce standard date formatting, labeling, and GUDID data submission requirements for class I and unclassified devices before September 24, 2020;
At this level, manufacturing best practice is to upload UDI data to the GUDID using a software-based solution and a staff expert or independent software vendor to act as an intermediary between the manufacturer and the FDA.
TRACTUS is fully integrated with the GDSN and GUDID, allowing for a real-time ability to scan all medical implants, adhering to the FDA's guidance.
The UDI rule has health care organizations and medical device suppliers looking at the most accurate ways of generating UDI-compliant labels, scanning them and getting the data into the necessary supply chain and electronic health record (EHR) systems, as well as the GUDID, according to David Coons, vice president of advanced markets and technology for Zebra Technologies.
For a draft guidance on the GUDID, go to:
Does the device production volume allow manual key-in of the information to the Global Unique Device Identification Database (GUDID), or will a software solution capable of automated transmission be needed?
Under the rule, manufacturers must also submit data on their products to the FDA's publicly accessible Global UDI Database (GUDID).
are required by the FDA's Unique Device Identification (UDI) Rule to be labeled with a Unique Device Identifier (UDI) meeting specified criteria, and for the Device Identifier (DI) to be entered in FDA's Global UDI Database (GUDID).
An FDA presentation released in March 2016 provides abundant details on requirements, label formatting, data required for submission to the FDA's Global Unique Device Identification Database (GUDID), and tiered compliance dates.
Speakers and panelists, including Dawn Fowler of Endologix, Melissa Finocchio of Biomerieux, and Jackie Elkin of Medtronic, will be on hand for extensive networking opportunities and to offer insight to UDI regulations, GUDID compliance, evolving global labeling requirements, and much more.