OTC Medical Device listing requirements
Does anyone have experience with listing an OTC medical device for sale? I ask because we are in the process of starting our own brand of otc eye drops and I can't find anything in seller central pertaining to listing restrictions of this type of product or what documents would be required of me before approving the listing, if any. We have an FDA approved manufacturer to partner with for manufacturing and packaging. More importantly, they will take care of any and all FDA regulations that are required for the development of this product on my behalf and they will guide me on what claims I can and cannot make.
I want to make sure I have no issues being able to sell this on Amazon before I commit to a very large purchase order.
Would the best approach be before placing this PO is to create the listing and submit for approval and see what they ask for?
Greatly appreciate anyone's insight
OTC Medical Device listing requirements
Does anyone have experience with listing an OTC medical device for sale? I ask because we are in the process of starting our own brand of otc eye drops and I can't find anything in seller central pertaining to listing restrictions of this type of product or what documents would be required of me before approving the listing, if any. We have an FDA approved manufacturer to partner with for manufacturing and packaging. More importantly, they will take care of any and all FDA regulations that are required for the development of this product on my behalf and they will guide me on what claims I can and cannot make.
I want to make sure I have no issues being able to sell this on Amazon before I commit to a very large purchase order.
Would the best approach be before placing this PO is to create the listing and submit for approval and see what they ask for?
Greatly appreciate anyone's insight
1 reply
Danny_Amazon
Hello there @Seller_nj8PIYNoGx6rj- thanks for starting this discussion here on forums!
If you haven't yet, I'd recommend reading through this help page on medical device listing requirements which includes everything from a compliance checklist to guidelines on labeling products.
From my understanding medical device items will require the 510(k) documentation from the FDA, but let me know what questions you have after perusing the above!
Thanks,
Danny
