I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner.
It's not like a physician prescribes a 23 & me writeup.
You think diagnostic services sold to doctors aren't a concern for the FDA? Virtually every medical product or service the FDA regulates is marketed primarily to doctors.
Anyways, my comment was a response to the commenter who claimed 23AM was marketed as "entertainment". Horseshit.
No, they need to prove to the FDA that their tests do each of those things. If they say the test lets you find out "if your children are at risk for inherited conditions", should the FDA just trust them about that? I mean, that's a pretty serious thing to be testing for.
> I think most people view their service as fun thing
If they were marketing as an entertainment product, this wouldn't be an issue. They are marketing it as a diagnostic product (and apparently submitted applications for FDA clearance as such, but then just decided to ignore that process and continue marketing it for diagnosing risks.)
Literally, my mom is the one who got me to send off my spit to 23andMe. She thinks it's fun and interesting but at no point has she indicated that she's thinking of it as a medical service - especially not one that replaces seeing a doctor.
>> "I think most people view their service as fun thing"
The problem is that's not how they are marketing it as others have pointed out. They market it as a serious health evaluation tool you can use as a step in preventing future illness.
Should personality and health quizzes in magazines also need FDA approval?
Q: Have you eaten fast food more than 3x this week?
A: If yes, you may be at risk for obesity (or just plain lazy)! See a medical professional for verification and treatment options! By the way, check out this insurance plan! And these nutritional supplements!
I mean there's a whole industry of publications, websites, media, and more dedicated to getting people to self-diagnose and self-treat all kinds of conditions and doing it without FDA approval...
I don't even think I've gotten to most of the egregious ones because they use trickier to find names. But they're all basically promoting self diagnosis and self-treatment of conditions that may or may not exist or methods of managing or treating conditions that do in fact exist.
Besides this not being part of the FDA's charter, what you're ignoring is that articles assist you (correctly or otherwise!) in self-diagnosis. An article does not in and of itself diagnose you with a disease or condition and thus can't by any stretch of the imagination be considered a Device.
Yes, that's what I view it as, as a subscriber to 23 and Me. Though, fortunately, I also haven't seen anything that as a real concern that I didn't already know about from family history.
I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner.
It's not like a physician prescribes a 23 & me writeup.