> Clinical labs are not regulated by the FDA, but fall under a far less arduous regulation known as Clinical Laboratory Improvement Amendments, or CLIA.<p>I know a bit about the clinical laboratory environment through a close relation. In fact, that person was the first clue I had that Theranos was BS. (This was before the WSJ article or any of the whistle blowers had come forward.)<p>Clinical laboratories are so resource constrained that FDA regulation would literally kill them. And many may not realize this, but 75%+ of any diagnosis is actually done by the lab. Care teams make hypotheses and labs reject them.<p>I feel somewhat sympathetic to this article's thesis, that these "fraud" laws are meant more as a bailout for rich and powerful people as a way to pin blame on a scape goat. A regular person defrauded by a bank or some other professional would have no hope of bringing their abuser to a criminal trial. But demonizing then CLIA loophole as if it is some ghastly deviation only fixed by the Powerful and Mighty FDA seems short-sighted.<p>Again, keep in mind that basically all lab scientists, all medical researchers who investigate lab procedures and all of the academics who study this and teach the next generation said Theranos was BS long before the government or press.<p>No one listened to them.