F
Frodeno
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.
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.