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A comment on Alphabet in bid to buy Fitbit. Parent comment

Re:Alphabet in bid to buy Fitbit by ofcrpls on Monday October 28, 2019 @04:47PM (#21381461)
It is due to the regulatory purview on the difference of calling something a "vitals display device" vs a "vitals monitor"

Source: Spouse, who worked on a field spO2 monitor at her first job and has since spent the next decade in the medical device regulatory industry.

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Re:Alphabet in bid to buy Fitbit by jschwartzi on Monday October 28, 2019 @04:54PM (#21381556)
Yeah, they would at least have to do a 510k submittal provided they could show a predicate device existed, and that there were existing standards that they could follow. If they're making an SpO2 monitor that doesn't work like any other SpO2 monitor on the market then the FDA would probably put them in De Novo hell for a very long time.
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