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Class II 510(k) question for device with different EU - US configuration

F

Frodeno

#1
Hello Everyone,

I need some guidance regarding regulations for a class II electronic and software driven monitoring device that we intend to market in the USA. The device integrates with other monitoring devices to give the user lots of monitoring options. The device has a GUI where the user selects different functions but for commercial reasons some of these functions cannot be implemented in the USA. Our software engineer can easily `grey out` these non-available options on the GUI menu but could the visibility of these options (even if they are greyed out) cause us a problem with our 510(k) ? Our engineer says its too much of a problem to remove the options completely from the menu. Can someone guide me to any FDA publication that speaks to this type of situation ?

Thanks in advance,

Frodo.
 
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kreid

Involved In Discussions
#2
I think you could make the case that the greying out of non-available options does not impact the use of the device and so it could be acceptable to the FDA.

You would need to back this stance up with:
  • evidence that the greyed options cannot be exercised through any means (the greyed buttons or other ways) and
  • evidence that they do not cause confusion (you would need to carry out usability studies on the US variant).
 

mihzago

Trusted Information Resource
#3
I agree with kreid.
I would also add to make sure that the "greyed-out" functionality is not required for the proper operation of the cleared device in the US. In other words, is the functionality or the data provided by the greyed-out options required to meet the intended use of the device cleared in the US.
 

yodon

Staff member
Super Moderator
#4
I'm not saying this *would* be a problem but certainly something to be aware of and prepared for.

The FDA frowns on "dead" code and by graying out options, you're pretty much advertising that there's code in the system that is unreachable through normal operations. Of course, the FDA is concerned about the anomalous cases, for example, what happens if the code somehow vectors into this dead code space.

If you actually compile out all that unavailable code (i.e., it's not represented in the binaries) you'd be in pretty good shape, I think.

Either way, if you address this in your risk assessment, you might be better off.
 
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