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

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 needs to be regulated. 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? 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. 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). 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.