Comment by adrr

Comment by adrr 4 days ago

3 replies

Sleeping on your back isn’t a medical treatment. It’s a snoring reduction. You can buy snore guards, nose strips, special pillows etc to prevent snoring and none of those require FDA approval because snoring isn’t a medical condition.

tptacek 4 days ago

Is it marketed as "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals"? That's one of three things that gets you categorized under the FDA regulation. There's even a term for it: "SaMD".

It seems less likely to me that this is Apple being ruthless or pigheaded and more than you really do have to be careful how you market your iPhone apps.

I take your point; the FDA doesn't recognize "snoring" as a medical condition (but OSA is!)

eli 4 days ago

So long as you're very careful what you say in the ad and within the app, sure.

kemayo 4 days ago

Yeah, but the question is really about how the app was presenting it. If it was making anything that sounded like a health claim...