Don't you think they have discussed this with the FDA in their series of communications, and received some guidance, leading up to the determination of whether ASepticSure is a medical device, and if so, what Class does it fall under?...
as DE pointed out in the CC, they agreed to not enter the USA hospital market until said determination but can, under their EPA labeling approval as a disinfectant, enter other markets in the USA such as the funeral and sports arenas...