It is very likely medical device.designation.of.smoking/vaping.devices.will.never.occur.in.any.country.
Just hurts SCAMydx's ability to fund future operations. Avoids current revenue and customer feedback that could prove more valuable.
That feedback could prove to be the catalyst for user acceptance of a product over competing vape pens, while generating revenue that could be used for lobbying, inventory or promotion once (if ever) medical device designation occurs.