Hello Anon,
If you are speaking about the US FDA GUDID, and it is just the checkbox which was checked in error, reach out to the Help Desk as they should be able to sort it. You may not need to go through getting a whole new entry for the product or even worse assigning a brand new UDI number to the product which impacts all of the labelling. Not sure exactly on the specifics, but if this is fields in the FDA GUDID which need to be addressed, definitely best to reach out to the Help Desk first.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 19-May-2022 09:59
From: Anonymous Member
Subject: UDI & GUDID
This message was posted by a user wishing to remain anonymous
Hello,
When listing my company's products in GUDID, the devices were classified as combination products by mistake.
When I tried to fix this error via the Device Identifier (DI) Record Details for Published Record module the combination product check box was locked.
The proposed solution was to issue a new DI for all IceCure produces.
- It is not clear to us if the old registration will be deleted once the new one submitted or not (hence, the devices will be registered twice).
- If the old registration (with the wrong combination product classification) will be deleted, for how long can we use the previous UDI to enter the product to the US.
Is there another method to address this issue?
Thanks