Product mistakenly flagged as medical device
Re: CASE 16926710951
I'm at a loss as to what else to do as I have been back and forth on this issue with Amazon support in the last 6-7 weeks or so. My product does not meet FDA threshold for medical device, which according to Amazon and FDA, needle size should be >0.3mm and mine is only 0.25mm. I tried to appeal and was asked to remove any image or product detail that could be perceived as a marketing claim, which I did, and even asked an independent reviewer to ensure no medical claim is being made.
I keep getting this response back from Amazon support: (2) the inclusion of medical marketing claims in the product details and/or images, or (3) a combination of both technical characteristics and marketing claims.
I have asked on multiple occasion if they can be specific as to which image or product detail they are referring to but I keep getting the same generic response (see below). Can this issue be escalated or reviewed internally?
__________________________________________________________________________
Hello ,
We received your appeal for the ASINs {___________}, but we are unable to reactivate your ASINs at this time.
The detail page or the images have to be updated as requested in the following paragraphs. Review the product detail page and images, and examine any claims related to health or safety carefully to ensure such claims are accurate and verifiable.
Why did this happen?
This product has been identified as a microneedling skin roller or similar product that is considered a medical device due to either
(2) the inclusion of medical marketing claims in the product details and/or images, or
(3) a combination of both technical characteristics and marketing claims.
Product mistakenly flagged as medical device
Re: CASE 16926710951
I'm at a loss as to what else to do as I have been back and forth on this issue with Amazon support in the last 6-7 weeks or so. My product does not meet FDA threshold for medical device, which according to Amazon and FDA, needle size should be >0.3mm and mine is only 0.25mm. I tried to appeal and was asked to remove any image or product detail that could be perceived as a marketing claim, which I did, and even asked an independent reviewer to ensure no medical claim is being made.
I keep getting this response back from Amazon support: (2) the inclusion of medical marketing claims in the product details and/or images, or (3) a combination of both technical characteristics and marketing claims.
I have asked on multiple occasion if they can be specific as to which image or product detail they are referring to but I keep getting the same generic response (see below). Can this issue be escalated or reviewed internally?
__________________________________________________________________________
Hello ,
We received your appeal for the ASINs {___________}, but we are unable to reactivate your ASINs at this time.
The detail page or the images have to be updated as requested in the following paragraphs. Review the product detail page and images, and examine any claims related to health or safety carefully to ensure such claims are accurate and verifiable.
Why did this happen?
This product has been identified as a microneedling skin roller or similar product that is considered a medical device due to either
(2) the inclusion of medical marketing claims in the product details and/or images, or
(3) a combination of both technical characteristics and marketing claims.
2 replies
Seller_fElMSF8nwwDWM
Is it possible if you an assist with escalating this issue?
@Daryl_Amazon @Jurgen_Amazon
Roxy_Amazon
Hello @Seller_fElMSF8nwwDWM,
Thank you for providing Case #16926710951 regarding your listing. We understand the challenges you've faced over the past 6-7 weeks trying to resolve this situation, particularly regarding the FDA threshold requirements and your efforts to remove marketing claims.
After reaching out to the responsible team regarding your specific case, we can provide clear steps to resolve this situation:
- Please create a new case with Seller Support specifically for the ASIN ending in WZQ7
- Upload 6 (six) high-quality images showing all sides of the product packaging - ensure all text and information is clearly visible
- Remove any prohibited medical device claims from your Product Detail Page:
- This includes terms like "anti-aging" in your title, bullet points, description, and backend keywords
- Review and remove any health-related claims that could classify the product as a medical device
These specific requirements will help our team properly evaluate your product and ensure compliance with our policies.
For more information please visit our help page: Restricted products.
Best,
-Roxy
