Going in circles with Restricted Products Appeal - 510(k) exemption
Not sure where to go from here. We have several products that have been mislabeled by Amazon as medical devices. Every communication we receive from Amazon tells us the submit the same information we have already submitted over and over again to correct the situation.
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When submitting our appeals, we get one of two auto-responses over and over again:
AMAZON RESPONSE 1
What actions do I need to take?
To reactivate your ASINs, send the following documentation and information:
-- The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product.
Additionally, if the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), then also provide the following:
-- The device manufacturer’s FDA establishment registration number or the owner or operator number.
-- The device name as it appears in the manufacturer’s device listing.
-- A purchase order, invoice, or letter, all must be written in English, from the manufacturer confirming that the device was purchased from the manufacturer.
AMAZON RESPONSE 2
We re-validated all the documents again, however, we need the below documents in order to proceed furthe;
What actions do I need to take?
To reactivate your ASINs, send the following documentation and information:
-- If the product does not require a 510(k), along with an explanation, please also provide a supporting document/proof to support the 510(K) exemption claims.
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We have provided all this info many times over a period of months now but cannot seem to convince Amazon that our product is not a medical device and is not regulated by the FDA, and therefore we have no 510(k) number.
This has been incredibly frustrating, as it is our top seller now that is being affected. And we have distributors of ours that sell this SAME PRODUCT, and their listings are active. We are the product's manufacturer, so it's embarrassing that we can't sell our own product but someone else can.
We don't know what else to do at this point, so I am hoping someone here can elevate our case.
Thank you
Going in circles with Restricted Products Appeal - 510(k) exemption
Not sure where to go from here. We have several products that have been mislabeled by Amazon as medical devices. Every communication we receive from Amazon tells us the submit the same information we have already submitted over and over again to correct the situation.
---------------------------------------------------------------------------------------------------------------------------------------
When submitting our appeals, we get one of two auto-responses over and over again:
AMAZON RESPONSE 1
What actions do I need to take?
To reactivate your ASINs, send the following documentation and information:
-- The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product.
Additionally, if the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), then also provide the following:
-- The device manufacturer’s FDA establishment registration number or the owner or operator number.
-- The device name as it appears in the manufacturer’s device listing.
-- A purchase order, invoice, or letter, all must be written in English, from the manufacturer confirming that the device was purchased from the manufacturer.
AMAZON RESPONSE 2
We re-validated all the documents again, however, we need the below documents in order to proceed furthe;
What actions do I need to take?
To reactivate your ASINs, send the following documentation and information:
-- If the product does not require a 510(k), along with an explanation, please also provide a supporting document/proof to support the 510(K) exemption claims.
---------------------------------------------------------------------------------------------------------------------------------------
We have provided all this info many times over a period of months now but cannot seem to convince Amazon that our product is not a medical device and is not regulated by the FDA, and therefore we have no 510(k) number.
This has been incredibly frustrating, as it is our top seller now that is being affected. And we have distributors of ours that sell this SAME PRODUCT, and their listings are active. We are the product's manufacturer, so it's embarrassing that we can't sell our own product but someone else can.
We don't know what else to do at this point, so I am hoping someone here can elevate our case.
Thank you
0 replies
Seller_0rXAME9V4LQSx
Whats the product?
We see this missmatch over things like tea and lip balm that mentions some type of "medical benefit" The AI just sees them make a claim of health benefit and assumes it must be a medical device since there are medical claims made.
Atlas_Amazon
Hello @Seller_g7XelMsXmpPD4
Thank you for the information provided regarding the issues that have been occurring with your products. I understand there have been specific restrictions regarding your products. What type of product are you currently selling? You mention the product not being regulated, do you have a specific case that you could share that has this information?
From the information you have shared, that is what our team will be looking for. We encourage you to provide more information or details regarding the steps you have taken. We have forwarded your feedback on this situation to the appropriate teams and will continue to monitor this situation.
Best,
Atlas
Seller_bbR4XLkBviRA8
You have entered hell. We do not even list products anymore on Amazon that we have the 510K for. The time and effort to get them reinstate is just not worth it.
