Should clinical software be treated as a medical device under FDA guidelines? (poll 2192543)

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Posted 2 years ago.

medical - 2 years ago

It would have to have a special set of rules similar to the standard FDA guidelines for medical devices but obviously when these rules were originally written medical software was not in their mind.

Again, their does need to be tighter regulations on the software since it does influence how all of the equipment runs and works so someone needs to take a look at it and regulate it better than it is now.

Should clinical software be treated as a medical device under FDA guidelines?