Re:FDA Warning Letter to 23andMe
by cbsmith on Monday November 25, 2013 @10:33PM
(#6798945)
And which ballpark would you say is closer to the area of a "food" or "drug"?
If you look at the FDA's mandate, it is pretty strongly oriented to products for treatment, not medical diagnosis. The medical diagnosis angle is mostly there due to certain forms of quackery.
Re:FDA Warning Letter to 23andMe
by EpicEng on Tuesday November 26, 2013 @03:39PM
(#6804035)
I develop medical devices use for diagnosis for a living. Some organization has to watch over this stuff, it just so happens to fall to the FDA. What's your proposal? Do you believe that these devices should not be regulated?
If you look at the FDA's mandate, it is pretty strongly oriented to products for treatment, not medical diagnosis. The medical diagnosis angle is mostly there due to certain forms of quackery.