Replies to post #40896 on Bioelectronics Corp (BIEL)

[Arizzle]

No, dead wrong. That could be the soonest that we can expect the FDA to announce the new class has been established and 510k applications can be submitted. BIEL will then have to submit one and it could take anywhere from 6mo or more for it to either be approved or rejected. If it is approved that would finally mean the the "FDA approval" that so many on this board erroneously toss around has actually happened.

[seven-up]

Now the 23 days is just my opinion based on how long it took for the FDA to finish reviewing the public comments 5/21/14 to 6/20/14. I hope it is soon, but I know nothing for sure. This is of course related to the new class being established only.

Thank you for your service.

link to 515 Project Status

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