Bioelectronics Corp (BIEL)

[Just No]

I don't think that is correct re/60 Days

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm

Keep in mind that the agency doesn't have to meet it's own proposed timelines, they are only what happens when everything goes smoothly.

Anyway, the FDA site says 90 days for communication of decision.

If I recall the average was 177 days in 2016. The agency hasn't changed that much since then.

https://www.emergobyul.com/resources/research/fda-510k-review-times-research

Having said that ours should go through fast, i.e. 90 days plus or minus.