We all agree with almost everything you say here, but you're missing the point.
Yes, BIEL had a hard time getting FDA clearance. They took baby steps, getting clearance for one small indication, then another, finally ending up with full body OTC for pain.
But imagine J&J wanting to sell the ActiPatch now. Imagine J&J partnering with Shenzhen CICD in China and submitting the 510(k) for full body OTC for pain. They name the ActiPatch as the predicate device. They prove that the device they want to sell is the EXACT SAME DEVICE AS THE ACTIPATCH, MADE BY THE EXACT SAME MANUFACTURER (Shenzhen CICD), MADE AT THE EXACT SAME FACILITY. The only difference is the logo.
The 510(k) process was very messy for BIEL "way back then" but the reason for that messiness was that BIEL had trouble proving substantial equivalence to a predicate device. J&J would not have this trouble proving substantial equivalence of their new device to the ActiPatch BECAUSE IT IS THE ACTIPATCH with a different logo.
You understand that generic drugs are not as difficult to get approved by the FDA as the original drug? The generic drug manufacturer doesn't have to repeat all that clinical testing -- they just have to prove that their active formulation is identical to the original drug.
Ahhh but really, never mind, J&J won't do this. Nobody will, IMO. It's academic because nobody thinks they can profit from selling the ActiPatch. BIEL is safe.
By the way, that "works better in females" problem was the result of BIEL trying to do their own clinical testing. BIEL was unskilled and inept at clinical testing (especially the Koneru Brothers). BIEL got lucky when a couple of skilled independent researchers decided to test the ActiPatch -- otherwise BIEL would STILL be chasing FDA OTC clearance, IMO.
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