Non-medical device software

I

iam1235

Starting to get Involved
Hello, we are a manufacturer and editor of class I software that will have to be in class IIa according to the regulation.
We are working on 2 projects with rehabilitation centers and hospitals, and we want to declare that the software under development is not a medical device, as it does not raise any alert and is used to collect and display the patient's vital parameters.
In your opinion how can it be declared as a diagnostic tool but not a medical device?
Thank you for your help,
 
Y

yodon

Leader
Super Moderator
When you say "diagnostic" then you're pretty much forcing it into a device category. Everything will come down to claims. I am pretty sure that even just collecting and displaying (some) vital parameters will push it into the device category (for example, the Owlet 'smart sock' was recalled because they marketed it as a commercial product but collection of blood oxygen levels put it into the device category, per the FDA). Not sure of your anticipated market, but if in the US, the FDA has a guidance on general wellness products that might help you see where the lines are drawn.
 
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