Bioelectronics Corp (BIEL)

[rrao11]

Hello all. Fellow long here. I work in the Pharma-Med. Device industry. The general guideline is for FDA to make the decision within 90 days, assuming that all the documents were submitted correctly and completely. If the FDA finds issues (which I highly doubt in this case - because of previously cleared devices), BIEL will have 180 days to address the issues and FDA will have another 90 days after the issues identified are addressed and communicated back to the FDA.

Hope this help.