Bioelectronics Corp (BIEL)

[uksausage]

unfortuantely the FDA process is at fault as well
there may be some substance in your observations but the fact is that in order to get anything that didn't exist before 1978 passed as a medical device you have to first try to get it categorized as something that did exist.

only then can you file the denovo application to get a new category and that takes extra information as you are then defining the category and associated verbiage that has to go on all products that are subsequently categorized that way.

FDA only clear 6 denovo applications a year so yes it is very slow but when you have a unique product the first of its kind that is what the US FDA does.

Shame Joe never told us this in 2009 but then he thought he had a product cleared for sale in Japan as well!