Personally I wish the FDA would get out of the business of validating each pregnancy test product on the market. I'd prefer that something like the UL be used i

Personally I wish the FDA would get out of the business of validating each pregnancy test product on the market. I'd prefer that something like the UL be used instead. First, you can't substitute UL for the FDA, they have very different mandates. However, with deep enough pockets, UL will hand-hold you through the FDA process. With the kind of funding 23andme has had, following FDA guidelines would not have been prohibitive. Second, pregnancy tests have been around for a relatively long time and are well-understood and established. The point is, if these are still under regulatory control, how can one argue that something much less established, understood, and developed, in terms of a take-home medical test should not be subject to the same rigor. What amazes me is that here on HN where we want the source to every driver, the schematic to every chip, and the right to know every secret of the government related to our personal information -- there are those who are arguing that we should not be allowed to have data pulled straight out of our genome and correlated with the data from other users unless fully sanctioned and sanitized by a government agency that is woefully incapable of operating in a fast-moving environment where uncertainty is okay and a REASONABLE EXPECTATION. The whole point of regulation is that having medical tests, drugs, and devices coming out of a "fast-moving environment" where "uncertainty is okay" is not safe. If you don't like this regulation, either lobby effectively to change it or get your medical services in a non-regulated jurisdiction. To not obey the regulations out of disagreement is like saying "I don't believe that stealing is a crime, so I'm immune to those laws". Take the liberation therapy for multiple sclerosis [1] as an example. Some claim it to be a revolutionary treatment that drastically reduces the symptoms and onset of MS. However, this has yet to be proven in a rigorous clinical trial. You would argue that as a consenting adult, paying for the procedure yourself, you should be allowed to do what you want. And you can, just not in the United States (or Canada, or many other countries). The FDA is not just going to let doctors start implementing this risky and unproven treatment [2]. There are too many people out there who assume that because a food, drug, medical test, device is being sold or used, that it is safe, that we can't just let them find out on their own. Just because you feel fully informed and consenting about these things, doesn't make that the norm. In the end, I'm still not clear on what your stance is. Is it for FDA reform and the reduction of its scope? If so, that needs to be backed up with a rigorous definition of how things stay safe in the new regime. Regulation is all about not letting stuff slip through the cracks. Is it that 23andme is not a medical device and should be exempt from regulation? If so, then when the very first pregnancy test was developed, it should have been regulation-free as well. [1] http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_insufficiency http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_in... [2] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...