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Questions regarding Medical Device Software "Level of Concern"

#1
In the FDA Guidance for for the Content of Premarket Submissions for Software Contained in Medical Devices, determining the Level of Concern requires a determination of what level of injury could result from failure. I have two questions:

1. Is this determination based on only failure or should injury that is a result of unintended use be considered here? I know it does for risk analysis but I'm not sure about "level of concern".

2. Would permanent or long-term reddening or scarring on 1 square inch of forearm skin be considered as "permanent damage to a body structure", resulting in this being considered a serious injury and therefore a Major level of concern?

Thanks.
 

yodon

Staff member
Super Moderator
#2
Re: Questions regarding Medical Device Software Level of Concern

1. Is this determination based on only failure or should injury that is a result of unintended use be considered here? I know it does for risk analysis but I'm not sure about "level of concern".
A little tricky to answer but the software level of concern is based on the risk of the failure of the software. Would your software prevent this unintended use? One example I can think of would be a hand-held neurostimulation device - delivers electrical current to treat pain. The software can control, to a degree, the electrical delivery. The hardware limits it, though, so the worst case of software failure would be pain (not a fatal shock). The treatment is intend for topical use but is not indicated for, say, migraines. In theory, you could cause brain injury if you used the device at max setting at your temples. The software can't control that and no failure would address it so to me, that would be out of scope of consideration for level of concern.

2. Would permanent or long-term reddening or scarring on 1 square inch of forearm skin be considered as "permanent damage to a body structure", resulting in this being considered a serious injury and therefore a Major level of concern?
I *personally* wouldn't consider superficial scarring as such but I would recommend getting advice from a regulatory expert. It just doesn't seem to be in the vein of other parts of the definition (life threatening, impairment of a body function, or medical or surgical intervention)
 

primavesvera

Starting to get Involved
#3
Hi, I thought I might use this topic, since it doesn't make much sense to duplicate it.
My problem is that I don't get certain things what FDA actually wants to see.
For example, from the guidance:
For Major Level of Concern Software Devices, this document should also include an annotated list of the control/baseline documents generated during the
software development process and a list or description of software coding standards.


What do they mean by the software coding standards? Is it about the programming style and practices or something completely different?
 
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