Yes, it does take time for FDA to update the GUDID. Typically I think they receive a list of new terms around the first of each month and get them entered within a week or so.
If you're making device changes, the 10 business day rule applies, but for GMDN changes you have more time. The GUDID guidance says, "If a GMDN term becomes obsolete, the labeler/LDE should update the GMDN term in order to pass validation when updating any other DI record attribute. An obsolete GMDN term doesn't require an update, in and of itself, but when editing other attributes the DI record would not pass validation/review without an active GMDN term."
https://www.fda.gov/media/86569/download------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 01-Nov-2019 10:07
From: Anonymous Member
Subject: GMDN term update in GUDID
This message was posted by a user wishing to remain anonymous
Hi,
This is regarding a published GUDID-DI record.
GMDN term of the device got updated and as per the 21 CFR 830.330(b) - If GMDN information changes, the updated information must be submitted within 10 business days of the change to GUDID.
I am trying to update the GUDID record, however, it is showing the old term. Does it take time for the FDA GUDID database to synchronize with the GMDN database? Has anyone faced the same issue before?
Thanks!