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Friday, July 07, 2017 2:59:20 PM
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!!!!!!!
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