UDI for device programmer and software

tehuff

Involved In Discussions
Need some help figuring out UDIs...
My company distributes a tablet computer with proprietary software loaded on it that is used to program one of our implantable devices. This programmer (tablet+SW) is only distributed to company field representatives, not to end users, and is one of several components used with the "system". The SW is not distributed separately,except in cases of an upgrade, in which the company representative will upload the new version of the SW onto the tablet/programmer. Users do not receive the software directly. Questions about UDIs:
1) Does the SW itself need a UDI (to be displayed on the startup or about screen)?
1a) If yes, does the UDI need to change if the SW revision changes (major revision with new features or user interface changes)?
1b) If yes, does the UDI need to change if the SW revision changes (minor bug fixes, no new features or user interface changes)?
2) Does the "programmer" (tablet computer+SW) require a UDI? It is only used as part of the medical device system and not as a regular computer, etc.

Hoping someone who works with devices that have a separate programmer (e.g. pacemakers, neuromodulation devices, etc.) has some insight for me. Thank you!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Since this is not being provided to end users/patients/clinical I don't think it requires UDI

from FDA

Am I a device labeler?​

A labeler is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.
 

tehuff

Involved In Discussions
Since this is not being provided to end users/patients/clinical I don't think it requires UDI

from FDA

Am I a device labeler?​

A labeler is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.
Thank you. I thought about that....But it does meet the definition of a finished device per FDA.
Finished device= Any device or accessory to any device that is suitable for use or capable of functioning. (21 CFR 801.3).
 
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