Yeah, it was difficult for me to see from the FDA's website how exactly you'd get approved. If you did have to go through De Novo or PMA then you're probably lo

Yeah, it was difficult for me to see from the FDA's website how exactly you'd get approved. If you did have to go through De Novo or PMA then you're probably looking at years and years if you can even get the regulators to accept it. It's not like there's a predicate device for what you're doing so there's nothing you can point to. From what I understand, De Novo is where cool ideas go to die. FDA protects people from a lot of bad devices, but it also makes it really difficult for people to innovate here. My last job was with a company doing a 510k and we were delayed 6 months while the branch of the FDA that handled ventilators tried to figure out how to work with the branch of the FDA that handled oxygen concentrators. I don't blame you.