Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
For Class I Stand alone software, UDI requirements are not clear. 

They state that Class I devices do not need to include PI, but version for software needs to be shown and this is PI.

1. What do you show on the User Interface (UI)? Do you just show a DI and the version? Ex. Version 3.1.1 and (01)12345678901234?

When change results in a new version or model, you must assign a new DI. 

1. For software which can rev constantly, how are people handling this? How do you determine when a software change is significant to the point of updating the DI?

Do you have a rubric for determining major vs minor when you roll the revision?​ For example, what comes after 3.1.1. Your rule for new DI may be similar to that.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 29-Jan-2020 16:09
From: Anonymous Member
Subject: UDI for Class I Stand Alone Software

This message was posted by a user wishing to remain anonymous

Hello,
For Class I Stand alone software, UDI requirements are not clear. 

They state that Class I devices do not need to include PI, but version for software needs to be shown and this is PI.

1. What do you show on the User Interface (UI)? Do you just show a DI and the version? Ex. Version 3.1.1 and (01)12345678901234?

When change results in a new version or model, you must assign a new DI. 

1. For software which can rev constantly, how are people handling this? How do you determine when a software change is significant to the point of updating the DI?