OTS (Off-the -Shelf) Software involved in error control and messaging

T

tazer

Involved In Discussions
Hi All,
I'm looking at the FDA guidance on the use of OTS in MD and have trouble understanding the requirement from §4 saying:
"What is the OTS Software intended to do? The sponsor’s design documentation should specify exactly which OTS components will be included in the design of the medical device and to what extent OTS Software is involved in error control and messaging in device error control."
What do you think is meant by "what extent OTS Software is involved in error control and messaging in device error control." and what's the impact on th documentation?
I'm using a communication OTS in a device that is wirelessly connected to other components, so some error messages are transfered via the OTS.

Thanks
 
Y

yodon

Leader
Super Moderator
Not sure if I can fully do it justice, but here goes. Are you relying on the OTS software to implement any risk controls? Message validation, message encryption, etc.? If messages aren't received / acknowledged, will the software manage the situation? If the OTS receives corrupted messages, is it properly handled (or does the system crash)? Those are the kinds of questions that need to be considered, I believe.

Do also be (very) aware that such software (aka SOUP) is very much a vector for cybersecurity attacks and so read the guidance documents for how cybersecurity is managed with SOUP.
 
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