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Regulations for Selling Convenience Kit vs. Selling Separate Parts

S

Sandman2002

#1
we seem to be stumped on the kitting issue. These are the questions: i) can you sell two FDA approved drugs at one price and send them in one box without that being a convenience kit? ii) what is the advantage to calling it a convenience kit and when would you want to do it vs. just selling products together
 
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M

MIREGMGR

#3
This question is in the "Medical Device" section, which makes me wonder if your explanation is complete or if I don't understand it. Is there some characteristic of the drugs or their use that causes them or a kit containing them to be regulated as a device, or a combination product? Or are they combined with devices to make up the kit, in which case they'd seem to be a combination product...?
 
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