The 510(k) number
Hi,
We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product
This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.
Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.
My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?
Any advice and help would be greatly appreciated.
Thanks
The 510(k) number
Hi,
We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product
This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.
Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.
My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?
Any advice and help would be greatly appreciated.
Thanks
Danny_Amazon
Hello @Seller_WsgxkJhoqWLWB- thank you for these details. While I can't speak to the situations of other sellers on the platform, I did want to let you know I have contacted our escalation team requesting their review and assistance on this issue. They may reach out to you through a new case ID, but I'll be sure to share any updates I receive on this thread.
Regarding the pictures, it may be beneficial to call out in the email that the instructions for use are located on the product's packaging to help avoid confusion.
Thanks,
Danny
11 respostas
Danny_Amazon
Hey there @Seller_WsgxkJhoqWLWB- thanks for sharing this question to forums! While other sellers chime in with their experience with this piece of documentation, I wanted to provide the relevant help page on medical devices, which require the 501k.
While I can't speak to other sellers, I am wondering if your product is categorized the same as the others on the website? It may be worthwhile to explore the possibility of shifting the category away from medical devices if that truly is not the best fit for the item.
Let me know if this helps, or if you've found a different approach in the past couple days since posting.
Thanks!
Danny
Danny_Amazon
Thanks for the update here @Seller_WsgxkJhoqWLWB- could you provide me with a Case ID you've connected with support on this topic on so I can take a closer look? Thanks!
-Danny
Seller_WsgxkJhoqWLWB
Hello,
Sure
Case ID 13320144691
Thank You
Danny_Amazon
Thanks much @Seller_WsgxkJhoqWLWB- it looks like the team there is currently investigating your appeal of the necessity to provide this documentation. Should that case get resolved without the exception granted, please let me know so I can review what escalation opportunities are available.
Thanks,
Danny
Seller_WsgxkJhoqWLWB
Hello,
Thank You For lookup at my Case.
I hope the team will accept our appeal for the exemption of the 510(k) Number issued by the FDA. as our product is not a medical device it is stickers that hide the pimple area.
I would also request you share your views with us on what opportunities are available to activate the listing again.
Thanks
Danny_Amazon
Hello @Seller_WsgxkJhoqWLWB- the best opportunity to re-activate the listing will be allowing the team to complete the review of the appeal, and then escalating further if need be. I do not believe there are other pathways available at this juncture.
I'll be sure to monitor progress in that case along with you to help drive a resolution here!
Best,
Danny
Seller_WsgxkJhoqWLWB
Hello Danny,
Following Case ID 13320144691,
My ASIN is still inactive & support is asking for The 510(k) number.
My question is:
1:Are Pimple Patches in the restricted category and providing The 510(k) number for this product is a must? If yes then we cannot provide The 510(k) number so we will delete our listing and stop selling this.
2:Did all existing sellers provide The 510(k) number? if No, why are we supposed to provide it?
3:Support also asked for Photos of the instructions included with the product. I have provided all photos which u can find in the attachment but support is still asking for Photos of the instructions included with the product again. Can you please guide me on which type of photos should we provide? Are these photos not accurate?
Danny_Amazon
Hello @Seller_WsgxkJhoqWLWB- thank you for these details. While I can't speak to the situations of other sellers on the platform, I did want to let you know I have contacted our escalation team requesting their review and assistance on this issue. They may reach out to you through a new case ID, but I'll be sure to share any updates I receive on this thread.
Regarding the pictures, it may be beneficial to call out in the email that the instructions for use are located on the product's packaging to help avoid confusion.
Thanks,
Danny
Seller_WsgxkJhoqWLWB
Hello,
Thank You for contacting the escalation team and requesting their review and assistance.
I will wait for the escalation team's contact with me.
Thanks
Danny_Amazon
Hello @Seller_WsgxkJhoqWLWB- I wanted to let you know I received a note from our team advising the team in case 13320144691 is the correct team to be connected with, and they will own the final review decision on this issue. I realize this was likely not the response you were hoping before but I am glad we were able to escalate to get an additional set of eyes on this.
Best,
Danny
