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	Do you need help with -- Product jurisdiction -- Device Status -- 513(G) submission -- Preamendment/Predicate device documentation -- Device labeling -- Premarket notification (a/k/a) 510 (k) issues ?

LET ME HELP YOU OVERCOME WHAT MAY SEEM TO BE FRUSTRATING ROADBLOCKS TO MARKETING YOUR DEVICE!

Don't be bullied into thinking that your product is not a device simply because it may have some chemical or biological activity. I know the vital precedents and I know how to help you get FDA approval for medical products which by virtue of their primary intended modes of action have been historically regulated as MEDICAL DEVICES!!!!!

Put my 34 years of experience as an employee of the US Food and Drug Administration

Eugene M Berk, President