So here's the recap: The FDA doesn't like that 23andme is providing data that in their minds at least, could be used to treat, diagnose yada yada yada.... some disease. See, the FDA wants jursidiction over all these activities, supposedly so they can assure the effectiveness of such treatments, preventatives, etc.
But OOPS! It looks like some other "medical devices" circulating over the internet have been allowed to roam free WITHOUT government censure or comment, even though their treatments and recommendations seem to also fall within the confines of section 201(h) of the FD&C guidelines.
But there is a difference between the two "devices". 23andme data used to come with recommendations to "take a look at", "consider", that sort of thing. The other "medical device" comes with stronger exhortative statements. Check out this link to what is known as the "statin calculator". Note that this document and attending excel spreadsheet are supplied with the intent to estimate disease risk and to recommend treatment.
Interestingly, the guidelines admit that the calculator has flaws, but that the flaws are minor enough to initiate "lifestyle coaching". I don't know exactly what that entails, but really, I haven't heard too many stories on the internet about doctors firing their patients who chose to ignore their 23andme results. (OK, maybe Jack Kruse.) But, I have heard stories of patients who were fired by their doctors when they chose to ignore their cholesterol or age panel and refused statin treatment after having that Very Important Discussion.
I actually did try out the online calculator (see the link above) and discovered that despite my stellar risk factors, by the time I am in my 70's or so, I would have to either be on statins or out of compliance with my medical professional's recommendations. Just because I would be old and still alive. For shame!
(Now gotta admit here that my PC physician isn't a big fan of statins. He was even a heart specialist in the mother country. He's not a fan of lots of drugs. With that in mind though, he finally did prescribe a statin to a buddy of mine, and several months later my buddy got cataracts so bad he couldn't drive. After two cataract surgeries he still dropped dead of a massive heart attack from his low fat diet.)
Since the recommendations and new calculator came out 3 months ago, there have been so many complaints that it was hard for me to find the link to the calculator. Perhaps others have been cajoled or shamed into removing their links. I tried to find a link to the software validation study that they submitted, but no luck. I did scroll through all the FDA warning letters since the 23andme letter was released, and I could not find a letter addressed to the American College of Cardiology and/or the American Heart Association addressing the deficiencies of their medical device. (Hmmm, looks like DNA genetek was busted, too.)
OK, now where was I? Oh yea, the medical device. In the industry, we have special technical names for such software. POS, hokkered, bone-headed, lol-what-were-they-thinking,....POS, more lols for everybody. The use of an Excel spreadsheet for a medical device is absolutely lol.