Bioelectronics Corp (BIEL)

[GetSeriousOK]

The reason BIEL's 510(k) attempts failed.......

Pretty much the only reason the FDA ever gives for rejecting a 510(k).....

"Failure to prove substantial equivalence to a predicate device."

Because that's all a 510(k) has to do.

How can you not know this?

BIEL chose a predicate device cleared for blepharasty. They needed to choose a predicate device cleared for musculoskeletal pain if they wanted clearance for musculoskeletal pain.

In my J&J example, J&J would choose a predicate device -- the ActiPatch -- that was cleared for musculoskeletal pain. In my example, I'm asking you to imagine if BIEL had that advantage "way back then."

I tire of this. Never mind, you go Slap That Ask now.