Earlier quoted context omitted.
> There is no valid, rational basis in fact for the medical device classification or the rationalizations used to justify it. I wouldn't be that certain. The situation with stuff like fakes and knock-offs is already bad enough as it is - at least for anything classified as "medical devices", be it condoms or hearing aids, the threat of the law is keeping bad actors reasonably at bay. You go and buy a hearing aid, you…
Fake hearing aids, or dangerous ones, would get rooted out quick. The function is the test of quality. There are laws that hold companies liable for material and actual harms caused by their products. There's no need for the FDA to be standing in the middle of this industry - there is no value add. Zero. Zip. Zilch. Nada. I have looked. I have tried to steelman its presence in the regulation of hearing devices for mo…
Ah and here I think we disagree the most - because in everything else you say, I think we are in agreement.
IMHO, the only thing keeping Alibaba and their dropshipper "friends" on Amazon and eBay scamming off elderly people with worthless junk is the legal protection. The scam problem is massive enough that it's gotten really annoying to shop on Amazon, and I say that as a "digital native" - remove the paperwork and you'll get the digital equivalent of ambulance chaser lawyers in less than a month. Scam "hearing aids" would not get rooted out - they'd infest the world.