Quote Originally Posted by cmailliard View Post
Yeah, part of it, or actually most of it, is because this is designed to go into the body. All the way from original QuickClot to Combat Gauze everything says "external use only". There is a distinction in the eyes of the FDA for something that goes in the body i.e. angiocaths for starting an IV or a monster one for a needle decompression. For invasive procedures they like a physician to have some oversight on that which is why Rx Only.

All that being said the only any hemostatic works is by applying at the point of injury, the artery, IN the body. If Combat Gauze had been released in a different manner stating "apply to injured artery" it too may very well have had a Class II Rx Only designation.
Ok, fuck the FDA then. If I'm bleeding to death I really don't give shit what the FDA would like....I'd like to continue living my life without some beaurocrat deciding if I have the authority to treat myself or not. Or my wife or kids or some innocent victim I came across.

I'm not bitching at you, just the insanity that is the government.

Do they regulate dildos? They go in the body as well.