Replies to post #43501 on Bioelectronics Corp (BIEL)

[seven-up]

I look at it everyday and it has not changed any information, since it when to "D"

[uksausage]

If I were to guess this could be due to the final order being significantly different to the proposed order. Hence a meeting to explain that prior to issuing the final order.

IMHO they are going to make the final order enabling OTC immediately not through special processes, just straight 501k submissions with special conditions (labeling).

there was no evidence submitted justifying keeping any of the devices in this category as prescription only devices.

They may want them to be OTC but not "on the shelves" like some items are but anything that puts the public closer to getting their hands on Actipatch in the USA the better.

[Simpsonly]

Must have been looking at something else - I printed this in February and it is intact - the FDA is currently working on the Final Rule - you posted the link to the the Proposed Order . . . . .