IN the world there are approx 27,000 hospitals.........of those hospitals approx 5,000 of them are in the USA under FDA rules.........so that means 22,000 hospitals are not under the FDA.......your Idea of not having FDA approval is a mute point the only place it matters is in the USA which is only a very small part of the market.........The products MFTH has to offer are great and its only a matter of time before we see more of there safety systems inside more hospitals........outside of the USA