Question -- What does "providing input" comment mean?
Dr. Jesse Goodman, Chief Scientist, said, "I have determined, in my discretion, that additional Agency consideration is not warranted" and simply suggested resubmitting 510(k) premarket notifications or "providing input into the recent CDRH process for reclassification of non-thermal shortwave diathermy devices."
Dr. Bob, PHD,
Dr. Goodman is trying to tell us, gently, that there is NO WAY that BIEL's product will EVER get FDA approval.
They read your testimony, on this board, that there is more healing power in a cell phone, house wiring, computers, and other appliances, than in the BIEL product.
You were very helpful to point out that the BIEL product is WORTHLESS.
So, if Andy wants to continue to "provide input", he is welcome to do so, but the FDA won't even bother to read it.
YOU have opened many eyes to the FRAUD that the Whelan family is perpetrating on the investing public.
You should get the 10% whistleblowers award, when the entire Whelan family is CONVICTED.
I don't think I said that electromagnetic or electric fields from power lines, house wiring, etc. have "healing power". Those things almost certainly have an anti-health effect because they ARE so powerful. I know of not one neurosurgeon who uses a cell phone without an ear piece.