Replies to post #17560 on Bioelectronics Corp (BIEL)

[uksausage]

I agree the new category is going to be created as there is no problem with that (just defining the category precisely and then the warnings etc that have to go along with any approved products)

However the FDA then has to authorize the individual products and give them the classification with any riders associated:
type 3 like current recoveryRx for eye surgery only
type 2 for OTC in pharmacy
type 1 for OTC general eg convenience stores!

each product can be separately classified and these classifications DO NOT have to come at the time when the device Category is announced but normally do.