Replies to post #70949 on Bioelectronics Corp (BIEL)

[Simpsonly]

NO! Absolutely and totally NO! That would be inappropriate.
510(k) submissions, and the like, are considered as having to do with proprietary information, owned by the submitter. In the case of BIEL and ActiPatch, the device falls within the new category established by FDA in in its Final Order in early October 2015, reclassifying such SWT devices as Class II from Class III.

Therefor, all information pertaining to the 510(k) submission to the FDA remains the property of BIEL, in order to protect its proprietary information and business positions such as marketing and sales plans. FDA will communicate with the submitter and then the submitter may disseminate information as and when it so chooses, without any obligation to do so.

Patience . . . . Soon, very soon . . . .