GUDID Accounts Now Available For Class II Implant Makers

Beginning Jan. 26, labelers of implantable, life-supporting and life-sustaining devices that are not Class III can register with the FDA’s Global Unique Device Identification Database. Labelers of all other Class II devices are to request GUDID accounts later in 2015, the agency said.

Labelers of Class III devices and devices licensed under the Public Health Service Act have been able to sign up for GUDID accounts since September 2013, and the FDA has required Class III devices distributed in the U.S. to carry UDIs since Sept. 24, 2014.

The notice reminds companies to organize, connect and validate data before requesting a GUDID account or submitting device identifier data. That’s because data that’s live in the GUDID database cannot be corrected or amended.

The FDA is working with the National Library of Medicine to develop tools that will let the public access GUDID data. Search and download functions should be available this spring, the agency says.

The FDA has also updated two GUDID resources: HL7 SPL implementation files and GUDID Data Elements Reference Table.

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