FDA News FDA guidance on Multiple Function Device Products (8/2020)

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yodon

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Hmm... I was following along fairly well until they got to the examples. How is a computing platform or a WiFi card a "function"? If you display information, wouldn't this make the screen a function? (To be fair, when these 'components' could affect the system, we do consider them in risk analysis and such, but to call them functions is, um, unexpected.)

It's been a month now since that was published; I wonder if anyone has had any experience with it?
 
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