Replies to post #145733 on Bioelectronics Corp (BIEL)

[DewmBoom]

I am glad you looked at this and I did not want to confuse people with too much information here. I have looked at this very carefully well before now and here what I found.

If you look at the definitions of all 510Ks as well as the EAP. The circumstances of the Actipatch does not fit any of the definitions.

For the traditional 510K, Biel already waited months to get the FDA approval for knee and foot. So, they paid their dues their. As for the specifics of the abbreviated and special 510K, they do not fit the exact definition for why Biel is submitting when you look at them. The EAP does not apply because the Actipatch is not a life threatening breakthrough technology.

The only thing we know is that Biel has a pre-meeting with the FDA, and during that meeting the FDA gave them guidance on how to submit for expedited processing knowing the circumstances, evidenced by this quote:

Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.

As I indicated before, the FDA drilled this to the nth degree already and there is no good reason for it to take any longer than 30 days. Biel is not making any changes to the device, they are just showing a clinical trial for back pain to expand the approval into full body muscle and pain.

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/