As OopsCriticality points out above, it&#x27;s incredibly difficult to judge the potential of Theranos&#x27; technology because they have so far refused to perform and&#x2F;or publish peer-reviewed randomized clinical data comparing themselves to the standard of care.<p>I can add some nuance to the WSJ article as a veteran of medical devices and FDA inspections:<p>The WSJ article quotes the inspection as a &quot;surprise&quot;. There are only two reasons this inspection should have been a surprise to Theranos. Either in their conversations with FDA they appeared to be less-than-forthcoming, or if they were not familiar with how the FDA operated. Pre-approval inspections (i.e. you submit an application to FDA and before they make a judgment they do an inspection of your site) are very common for new technology and in some cases mandatory. <i>When</i> exactly they show up you don&#x27;t know, but you plan for them to show up, and you expect it within a certain window of time.<p>Theranos CEO Elizabeth Holmes has been vocal about the FDA exercising oversight over all &quot;lab developed tests&quot;, i.e. novel testing methods developed by a laboratory for use only by that laboratory and not for sale to others. Currently, these tests are not regulated by FDA, but FDA&#x27;s sister organization the Centers for Medicare and Medicaid Services (CMS), under a set of regulations called CLIA. CLIA regs are not as stringent as FDA oversight and are more about good laboratory practices as opposed to the safety and efficacy of any new technology. So, Theranos and Holmes are trying to hold themselves to a higher standard, which is admirable.<p>The caveat with doing that is that you should be familiar with what that standard is going to be. I am suspicious that we&#x27;re getting the full story from the Journal article, because I find it bizarre that no one at Theranos thought that FDA would consider their &quot;nanotainers&quot; a medical device: when FDA gets involved, anything that is part of a diagnostic system gets their oversight. Someone with 3 months experience in medical device regulatory could have told Theranos this.