P
Hello everyone,
Thanks for taking the time to read this, and hopefully for your valuable insight.
I am currently negotiating with a Chinese manufacturer who will produce hydrocolloid and adhesive bandages for me. Im planning to bulk ship the bandages in printed wrappers to the US to my warehouse where they will be assembled into retail packaging and sell them through a convenience store distributor.
These will be branded products - ie the wrappers are printed with a logo as is the secondary packaging.
My questions are:
1: Do i need to register as a manufacturer with the FDA and obtain 510K?
2: Do i need to submit the bandages for testing upon receipt?
I would really appreciate some advice regarding this issue, and any other issues which i may be facing and not realize

Thanks
D
Thanks for taking the time to read this, and hopefully for your valuable insight.
I am currently negotiating with a Chinese manufacturer who will produce hydrocolloid and adhesive bandages for me. Im planning to bulk ship the bandages in printed wrappers to the US to my warehouse where they will be assembled into retail packaging and sell them through a convenience store distributor.
These will be branded products - ie the wrappers are printed with a logo as is the secondary packaging.
My questions are:
1: Do i need to register as a manufacturer with the FDA and obtain 510K?
2: Do i need to submit the bandages for testing upon receipt?
I would really appreciate some advice regarding this issue, and any other issues which i may be facing and not realize


Thanks
D