&gt; Which devices and drugs were 23&amp;Me selling?<p>They were marketing their genetic testing kits and related services for diagnosing genetic diseases and risks. That made it a &quot;medical device&quot; within the scope of the Food and Drug Act, which means that they needed to actually have specified level of testing establishing the validity of the things its was being used to assess.<p>The FDA noticed the violation, notified 23andMe, said, if you want to keep doing this, you need to meet the requirements, and please tell us how you plan to come into compliance. And 23andMe blew them off for quite a while, so the FDA enforced the law.