Replies to post #110719 on Bioelectronics Corp (BIEL)

[Duke2484]

Umm, YEAH, because EVERYONE knows what the FDA rules and Regulation and packaging requirements are going to be. GEEEEEEEZZZZ!!!!!!

Umm, YEAH, actually they DO.

Allow me to educate you, I do this for a living.

1) FDA labeling standards: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095308.pdf

2) FDA packaging standards: https://www.iopp.org/i4a/pages/index.cfm?pageid=399

So I'll say it again... If my company had a 15 year head start we would have everything lined up in anticipation of 510k approval. BIEL and its management, not so much.

GEEEEEZZZZZZZZ!!!!!!!