The story you've linked to is where the FDA shut down some private individual selling genetically modified dogs to the public. But yes, the FDA aren't complete

The story you've linked to is where the FDA shut down some private individual selling genetically modified dogs to the public. But yes, the FDA aren't complete morons. If you're selling genetically modified dogs you're obviously selling the results of an unapproved medical procedure to the public, even if all you say about it is that you're selling fluffy friends to the public. The second story you've linked to is one where someone was clearly trying to sell a replacement for breast examinations to the public. I've never heard about the "sensor pad" before, and there's probably a good case to me made for such a device being more beneficial than not, and that the FDA made a mistake etc. But I think their process is more sound than not in demanding clinical trials of these sorts of products. This is because in practice people will use them as a replacement for going to their physician, so having some DYI breast cancer scanning kit doesn't just need to be harmless in isolation. You also need to consider the increased death rate from people not going to their doctor for an examination as a result.