The frustration directed towards the FDA in the 23andMe threads is not surprising, but short-sighted, IMHO. Sure, there are likely inefficiencies in the way the FDA operates, in a micro-sense, but in the macro-view, this sort of stuff <i>needs</i> to be regulated.<p>Many simple take-home tests that are arguably much more time-tested, reliable, and accurate than 23andMe's DNA services are FDA-regulated. If your basic take-home pregnancy test is FDA regulated, why should 23andMe be exempt? Or would you prefer a world where all of these tests were unregulated?<p>Not everyone does their research. Not everyone is intelligent enough to understand the implications of medical tests, drugs, and devices - regulation protects the vulnerable among us.<p>As an aside, I've worked in medical devices for most of my career. All other things remaining equal, engineering teams in these companies are no different, talent-wise and quality-wise, than most teams you'd see in other industries. Take the sloppiest engineering team you've worked with, now imagine them working on a clinical product with the potential to cause real harm to people (physical or psychological).<p>It is the regulation (FDA and others) that ensures that these teams "raise their quality game", so to speak. It is not perfect by any means, but I don't dare imagine the alternative. Yes, the regulation is a massive pain. I experience it first-hand. It slows things down, has massive associated costs and can even stifle innovation. The general trade-off, however, is worth it, IMHO.