I suspect we're going to get a lot of dichotomous responses to this.
1) the FDA has one job and this is it: if you do something which impinges on information in clinical sciences applied to humans they have a role to play and there is a process.
2) this is why we "cant have nice things" because basic indicative feedback on your own state from a simple sensor can't be enabled because <reasons>
Even regarding the first view, I don't see how blood pressure data differs significantly from weight data, and bathroom scales do not need FDA approval.
Notwithstanding agreeing I suspect this is one of the grandfathered in things. Calibration is pretty big in this, the watch methods have massive epidemiological evidence behind them but it remains a model, and with issues around skin colour (tattoos) which also dogs finger clamp O2 meters.
People often say if we invented beer now, the FDA would forbid it.
I suspect we're going to get a lot of dichotomous responses to this.
1) the FDA has one job and this is it: if you do something which impinges on information in clinical sciences applied to humans they have a role to play and there is a process.
2) this is why we "cant have nice things" because basic indicative feedback on your own state from a simple sensor can't be enabled because <reasons>
Even regarding the first view, I don't see how blood pressure data differs significantly from weight data, and bathroom scales do not need FDA approval.
Notwithstanding agreeing I suspect this is one of the grandfathered in things. Calibration is pretty big in this, the watch methods have massive epidemiological evidence behind them but it remains a model, and with issues around skin colour (tattoos) which also dogs finger clamp O2 meters.
People often say if we invented beer now, the FDA would forbid it.