How does a Kit Assembler proceed after FDA Establishment Registration?

[belemsanchez]

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!

 

[Ronen E]

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!

Hi,

Hopefully you will find all the answers here.

Cheers,
Ronen.

 

[belemsanchez]

Thanks a lot, but I haven't found my answer in this guide, I need to know if our procedure pack, which is similar to Laryngoscope Kit, but my question is if the assembler have to list (Device listing) only the convenience kit? the kit contains medical devices but one is class II, so, the procedure pack will be a class II (like EU 93/43/EC)?. Please, I can't find answers to my question, I don't know if it's enough that each medical device will be listed (device listing or 510k if applicable). My question is very urgent because we want to export USA asap.

Thanks a lot.

 

[Ronen E]

Thanks a lot, but I haven't found my answer in this guide, I need to know if our procedure pack, which is similar to Laryngoscope Kit, but my question is if the assembler have to list (Device listing) only the convenience kit? the kit contains medical devices but one is class II, so, the procedure pack will be a class II (like EU 93/43/EC)?. Please, I can't find answers to my question, I don't know if it's enough that each medical device will be listed (device listing or 510k if applicable). My question is very urgent because we want to export USA asap.

Thanks a lot.

Hi,

All the answers are there. If you expect someone to do the digging for you, perhaps you should consider paying something. Especially if you need it urgently. If I knew the answer straight away I would have already given it to you. What I do know is that this sort of answers is there, and that I can find them - because I've done it countless times. This is what regulatory consultants do for a living.

You might still get lucky through someone who already knows the answer coming across this thread or someone willing to do the work for you, for free.

Cheers,
Ronen.