FDA 510(k) Issue
I am writing in reference to case number 17753231891, regarding the approval process of my product listing. I would like to kindly express my full willingness to cooperate and comply with all Amazon policies and requirements.
Despite having submitted all the requested documentation, I received feedback stating that:
“The FDA 510(k) provided does not cover this product. This product is a XXXXXX, however, the 510(k) provided is for a different product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request.”
I am having difficulty understanding this response, as the FDA 510(k) I provided matches exactly the product name used in the listing title. For this reason, I respectfully ask for your help in clarifying what might be causing this issue.
Thank you very much in advance for your time and support.
FDA 510(k) Issue
I am writing in reference to case number 17753231891, regarding the approval process of my product listing. I would like to kindly express my full willingness to cooperate and comply with all Amazon policies and requirements.
Despite having submitted all the requested documentation, I received feedback stating that:
“The FDA 510(k) provided does not cover this product. This product is a XXXXXX, however, the 510(k) provided is for a different product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request.”
I am having difficulty understanding this response, as the FDA 510(k) I provided matches exactly the product name used in the listing title. For this reason, I respectfully ask for your help in clarifying what might be causing this issue.
Thank you very much in advance for your time and support.
0 replies
Seller_AudzIJ3ldX5ze
Hi,
Support is now requesting that I provide the following information. However, I have already submitted this documentation previously, but I am being asked to provide the same information again. The request is as follows:
What actions do I need to take?
To reactivate your ASINs, send the following documentation and information:
-- 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.
Could you please assist me with this matter? Thank you very much in advance."
Cooper_Amazon
Good Afternoon @Seller_AudzIJ3ldX5ze,
I wanted to reach out to you regarding CASE ID 17753231891. I noticed there is a lot of back and forth between yourself and the support team.
While I am not an expert in Medical Devices, generally speaking, there appears to be quite a bit of misalignment regarding the branding of the product, the information shared to Amazon and the information on the FDA screenshot.
This may be why the partner team continues to request:
- 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.
As the product you are trying to get approved is currently a 'Generic' product, you will not be able to change the brand of the listing to a branded product per the Amazon Generic Product Policy if this is preventing you from listing the ASIN.
A new ASIN will need to be created and the information between all the parties involved should match exactly (For example: docs you submit to Amazon, information you list on the detail page, and information you have approved through the FDA about your product should all match).
If you have questions about streamlining information, I am sharing the Medical Devices help page. You may also reach out to Selling Partner Support at anytime for further support. Feel free to let us know if you have any questions regarding the information shared above. Have a terrific rest of your Tuesday and take care.
Sincerely, Cooper_Amazon
