Yes, absolutely. You have to remember that UDI is from the consumer, patient, physician, healthcare professional, etc., point of view. Brand X with UDI 123 is different than Brand Y that should have UDI 456. Consumers would see these as two completely different products, therefore need different UDIs.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Mar-2019 00:01
From: Anne LeBlanc
Subject: Change in Brand name / GUDID
Yes, that is the rule.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 12-Mar-2019 17:07
From: Jon Cook
Subject: Change in Brand name / GUDID
Does a change in a product brand name require a new DI and subsequent new DI record input into GUDID?
All other elements of the device/product remain the same. This would be a re-branding (name) change only.
Looking at the GUDID Data Elements Reference Table, the Brand Name field is not editable, and the New DI trigger is 'yes'.
Based on this, am I correct in assuming I need a new DI, and a new DI record into GUDID?
Thanks,
Jon
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Jon Cook
San Jose CA
United States
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