Bioelectronics Corp (BIEL)

[kidnova]

No, that's not the current status at all. Technically, they are currently able to achieve approval as a Class III device via the 510k process, however the FDA simply isn't going to approve any more of these submissions until a final rule is issued based on the recent panel discussion.

All signs point to the FDA issuing a final rule classifying all PEMF devices as Class II devices requiring special controls, including submitting clinical trial data. Once that rule is issued, then BIEL will have to submit the required data in order to obtain approval as a Class II device for prescription use. At no point during the discussions was OTC approval even mentioned as a possibility. If OTC is still the goal then BIEL has a very, very long road ahead of them.

In none of these scenarios is a PMA required.