Replies to post #1637 on Bioelectronics Corp (BIEL)

[J-Rhino]

Do you know the timetable on FDA approval for OTC in the US?

[IZZYBOY]

The application process is not definitive. After filing their 510k with the FDA, the FDA has 90 days to respond. Respond being the operative term, that response can include any of a variety of options including; approval, rejection, questions (most common), clinical data, etc.

Upon receipt of any requested supplemental information, the FDA has an additional 90 days to then respond. This can be a tortuous and infuriating process. It also can proceed smoothly (but rarely quickly).

If the FDA requires that additional clinical trials be conducted, it can take a very, very long time.

I guess what I am trying to say is that no one can predict a time frame or a conclusion when dealing with the FDA. When the messiah states that it is "not an issue" he clearly has never dealt with the FDA nor does he know anything about the process.

Incidentally, I, nor anyone that I know, has EVER heard of an FDA investigator recommending a predicate device to use as the basis of a 510k. Might have happened but it would be a landmark event in the agency's history.