Unique Device Identifier for updates to legacy standalone software

K

kreid

Involved In Discussions
Hello,
One of my clients has a Class II standalone software marketed in the USA.
It is currently on the market and the current and recent versions have UDI per the 21CFR830 regulation
However, they also have legacy versions of the same product being used by clients, legacy - as in sold prior to UDI and hence these versions do not have UDI.
If my client needs to do some maintenance of a legacy version, say a bug fix, will they need to attach a UDI to the updated legacy version? For example if their current product is Acmesw v4.2 and a client is using a legacy version Acmesw v2.1 and v2.1 needs a bug fix and becomes v2.2
If so, will the DI be the same as that of the current marketed version?
Thanks, in advance.
Kreid
 
Y

yodon

Leader
Super Moderator
This isn't going to answer your question but this approach may create a configuration nightmare! Why not just push the old clients up to the latest software? Maintenance and management costs will go down.
 
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