Bioelectronics Corp (BIEL)

[kidnova]

That was their initial rulemaking notice, but if you read further into the document you're looking at you'll find their new recommendation:

Summary
SWD devices are currently classified in Class III. In light of the information available now, the Panel will be asked to comment on whether SWD fulfills the statutory definition associated with a Class III device designation. FDA believes that these devices may be more appropriately regulated as:
? Class II, meaning general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness
As opposed to:
? Class III, meaning
o insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness, and
o the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.