Bioelectronics Corp (BIEL)

[seven-up]

Hey Limitx21
Thanks for your service for freedom
We are waiting for the FDA to release the Final Order for the new class for SWT

There was a total of 400 plus comments received and it looks like 80% of those were related to Biel.
If the proposed rule was accepted as written we would have to submit a 510K, which Biel should be ready to do, the time that the FDA will required is a guess.

Just my opinion but I believe that the comments have made a big impact on the FDA folks and the proposed rule could be in a revision mode now... Just speculation... We should be getting close to the new class, I bought more shares today...

the link is to the proposed rule.. which is a technical correction
http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0378-0049

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm
515 Project Status

Task A: FDA collects existing information and assesses the risks and benefits (See Docket FDA-2009-M-0101 for information submitted to FDA by manufacturers of these device types)

Task B: FDA convenes a meeting of the advisory committee (panel) to request input on the classification of the device type.

Task C: FDA issues proposed order, which proposes classification of device type into Class I, II, or III

Task D: FDA reviews and considers comments provided

Task E: FDA issues final order, which finalizes classification of device type into Class I, II, or III

Device

CFR

Product Codes

Tasks Completed is "D"

shortwave diathermy 890.5290(b) ILX A, B, C, D
Proposed Order
Panel Meeting