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Please, my company wants to place on the US market a medical device kit (convenience kit) as assembler. It is an european company. We have registered our Facility (Establishment Registration) and paid. What is the following step? Do we have to list (Device listing) only the convenience kit? the kit contains medical devices and not medical devices. Or do we have to list all components of convenience kit as assembler or is the manufacturer who has to do it? Do we have to list medical devices components as assembler?
It is my first time working at FDA and as assembler so all help is welcome!
It is my first time working at FDA and as assembler so all help is welcome!
