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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 fiel
by ofcrpls 7y ago
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.
- jschwartzi 7y agoYeah, 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.