Courtesy notification of news from FDA:

The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID). As a medical device manufacturer or other organization responsible for reporting medical device UDI information to the GUDID, i.e., a Labeler, you may be affected by these initiatives and need to react promptly.

Medical Devices Missing in GUDID

Scope: Organizations receiving an FDA email regarding devices not in the GUDID

Issue: FDA is reviewing registered establishments and listed devices in the FDA Unified Registration and Listing System (FURLS) database and contacting those organizations that have one or more devices not reported in the GUDID. FDA expects organizations comply with UDI regulations including UDI labeling and GUDID reporting as necessary and within the now past deadlines.

Action: If an organization receives such a message, they should promptly evaluate their listed products in FURLS and determine why any device is not reported to the GUDID. Some devices may be delinquent in being reported and other devices may have a reason for being omitted from the GUDID. It is advised any necessary compliance activities, e.g., UDI labeling and GUDID reporting, be acted upon promptly.

Due Date: As soon as possible (must comply with FDA UDI regulations, see UDI website)

Obsolete GMDN Codes in GUDID

Scope: All Labelers reporting medical device UDI information to the FDA GUDID

Issue: FDA recently published information on the GUDID website and sent corresponding emails notifying Labelers of the FDA plans to include the Global Medical Device Nomenclature (GMDN) Term Codes on the public AccessGUDID database. As of August 14, 2023, these codes and the status (active/obsolete) will be added to the current GMDN name and description currently published on AccessGUDID. FDA is advising all Labelers to ensure that their reported GMDN codes and/or FDA Preferred Terms (PT) are accurate and active (not obsolete) as required by regulation 21 CFR 830.330(b) prior to the publication in the AccessGUDID.

Action: All labelers should promptly identify their reported GMDN and FDA PT codes. GMDN codes can be verified through a GMDN subscription service. GMDN subscription plans with the “My Terms” feature can quickly see their codes and status. FDA PT codes can be verified using the FDA GUDID web interface. If changes are required, submit an updated UDI record to the FDA GUDID.

Due Date: Verify and update GMDN and FDA PT Codes in GUDID on or before July 31, 2023.

Reed Tech Support
Reed Tech will continue monitoring any updates pertaining to these topics. Contact Reed Tech if you need to make new, initial medical device submissions to the GUDID or if you need to update existing GUDID records.