URGENT HELP needed to appeal restrictions: 510(K) Exempt Medical Device Classification
Hi,
I'm a bit overwhelmed by the situation, our ASIN has been classified as restricted by Amazon because they declare it to be a medical device but it is exempt and we should be able to sell it (Class 1 510(K) Exempt, Product Code: GED). We have followed all steps and provided all documentation to Amazon for the reinstatement of our ASIN, namely: namely: Product Instructions, Product Packaging Images (all sides), FDA 510(K): Product Instructions, Product Packaging Images (all sides), FDA 510(K) Exemption Documentation, FDA Registration Documentation, Device Name Screenshot, Manufacturer Invoice and more. We are also confident that we have removed all medical claims and technical specifications from Amazon's listing and product packaging.
Yet all I receive are robotic responses from Amazon explaining that we have not removed all medical claims or incorrect technical specifications. I am not sure of the best way to appeal this case because we have been going round in circles for over 3 weeks with Seller Support.
Amazon has informed us that over 500 units under this ASIN are at risk of disposal by Amazon if this case (ID 14033461541) is not resolved and the restrictions are not lifted before November 18, 2023 (11/18/2023). Please understand that Amazon's removal of our inventory is a situation we want to avoid at all costs, so it is essential that this case is resolved before November 18, 2023 (11/18/2023).
To those who have experienced a similar case or those who can escalate this case, your help would be IMMENSELY appreciated.
PLEASE HELP, THANK YOU
ID 14033461541
@Tatiana_Amazon @Topher_Amazon @Jameson_Amazon
URGENT HELP needed to appeal restrictions: 510(K) Exempt Medical Device Classification
Hi,
I'm a bit overwhelmed by the situation, our ASIN has been classified as restricted by Amazon because they declare it to be a medical device but it is exempt and we should be able to sell it (Class 1 510(K) Exempt, Product Code: GED). We have followed all steps and provided all documentation to Amazon for the reinstatement of our ASIN, namely: namely: Product Instructions, Product Packaging Images (all sides), FDA 510(K): Product Instructions, Product Packaging Images (all sides), FDA 510(K) Exemption Documentation, FDA Registration Documentation, Device Name Screenshot, Manufacturer Invoice and more. We are also confident that we have removed all medical claims and technical specifications from Amazon's listing and product packaging.
Yet all I receive are robotic responses from Amazon explaining that we have not removed all medical claims or incorrect technical specifications. I am not sure of the best way to appeal this case because we have been going round in circles for over 3 weeks with Seller Support.
Amazon has informed us that over 500 units under this ASIN are at risk of disposal by Amazon if this case (ID 14033461541) is not resolved and the restrictions are not lifted before November 18, 2023 (11/18/2023). Please understand that Amazon's removal of our inventory is a situation we want to avoid at all costs, so it is essential that this case is resolved before November 18, 2023 (11/18/2023).
To those who have experienced a similar case or those who can escalate this case, your help would be IMMENSELY appreciated.
PLEASE HELP, THANK YOU
ID 14033461541
@Tatiana_Amazon @Topher_Amazon @Jameson_Amazon
26 replies
Seller_vSOOwekJLU6c0
Ive had quite a bit of products labeled as medical devices (even though they were beauty products but whatever).
I was successful in my appeal to prove its a Class 1 device very quickly.
I would suggest updating your product copy to remove these keywords as Seller Support is stating. It triggers problems on your account caused by the Amazon bots.
Stevie_Amazon
Hi there @Seller_H7hAJ6vc4p693,
I hope this finds you well!
I understand you have concerns with a product being flagged for noncompliance of a restricted product policy.
As I see by the amount of information you have provided, you understand the policy in question as well as what to provide in order to prove your item is compliant. However, there is still something about your product or listing that is violating the medical devices and accessories policy.
You will need to ensure even the images on your listing do not mention or elaborate to anything that has to do with medical procedures, devices, and anything alike.
If you have further questions, do not hesitate to utilize this thread. The forums community and I are here to support you!
All the best,
Stevie
Atlas_Amazon
Hello @Seller_H7hAJ6vc4p693
I understand you have taken numerous steps to resolve this issue with the your listing being identified as a medical device. I have gone ahead and forwarded your information to another team as your issue exceeds our ability to assist in this space.
Please ensure that your contact information has been updated so that we may reach you. If you have any additional updates to provide, continue to refer here support.
Best,
Atlas
Seller_H7hAJ6vc4p693
If anyone encounters a similar case in the future, perhaps this can help. I noticed that the changes made to the title and description via the Product Details page were NOT updated at all since the Details page was removed by Amazon's bots over three weeks ago. Maybe that's why I keep getting bot responses from seller support stating that I haven't removed all medical marketing claims. I have opened a new case with Seller Support to get the changes updated.
I'd still like Seller Support to tell me exactly where the issues are, so that we can solve this case. This is a stressful situation for us.
@Stevie_Amazon@Atlas_Amazon
Case ID 14187129731 / 14187129731
Seller_rUwUi6FzXBTbk
Hi, do you know what keywords or claims are triggering the system? If not I would figure that out first then update or reach out to seller support to fix the changes in the title, listing description etc. in order to remove those claims that require 510K.
