Restricted Product - Open Case- Not Medical Device
Hello
My asin was classified as a medical device. I appealed by sending pictures of each side, instruction manual pictures, and proof it doesn't need FDA approval 25 days ago.
I have a open case related with a product that Amazon said its a medical device and I send all the proof that the product doesn't required FDA document provided by FDA, but every time they answered the same. and looks like don't read the attachments
My question is: How I can escalate to other Amazon corporate team, I have my inventory already and I cant sell it because my listing is inactive
Please if somebody has any advice or recommendation I really appreciated
Kind Regards,
Restricted Product - Open Case- Not Medical Device
Hello
My asin was classified as a medical device. I appealed by sending pictures of each side, instruction manual pictures, and proof it doesn't need FDA approval 25 days ago.
I have a open case related with a product that Amazon said its a medical device and I send all the proof that the product doesn't required FDA document provided by FDA, but every time they answered the same. and looks like don't read the attachments
My question is: How I can escalate to other Amazon corporate team, I have my inventory already and I cant sell it because my listing is inactive
Please if somebody has any advice or recommendation I really appreciated
Kind Regards,
6 replies
Emet_Amazon
Hello @MFG23,
This is Emet from Amazon to help you with your concerns.
My asin was classified as a medical device. I appealed by sending pictures of each side, instruction manual pictures, and proof it doesn't need FDA approval 25 days ago.
Thank you for your post, I see there is a concern with your listing being removed as a medical device.
I have a open case related with a product that Amazon said its a medical device and I send all the proof that the product doesn't required FDA document provided by FDA, but every time they answered the same. and looks like don't read the attachments
As you mentioned having provided all the requested information, I would need you to clarify what exactly was requested in your situation, what type of proof did you provide that the product does not require FDA approval?
Can you provide the original notification or policy concern, which also typically includes the dispute requirements to show your products comply with our policy?
My question is: How I can escalate to other Amazon corporate team, I have my inventory already and I cant sell it because my listing is inactive
We will need to 100% verify the product meets our requirements prior to the listing being reactivated. Once we can confirm the above information and requested documentation or supporting evidence it may be eligible for reactivation.
Since this is associated to medical devices, I would also like to clarify if you’ve reviewed the medical devices and accessories help page to verify if your product meets our requirement to be sold without restriction?
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
Emet_Amazon
Hello @MFG23,
This is Emet from Amazon to help you with your concerns.
As Amazon customer service suggests I download the certification which proves that my product has a 510(k) exemption from the FDA web page, the pictures, and I still haven't a response from Amazon. I Submitted all the documents and my ID case is No. 12766366701
Thank you for providing this information. My goal is to give you further assistance.
As it does appear the current situation exceeds our ability to assist in this space, I have forwarded your information to continue researching this matter further.
I appreciate you providing updates about your account. Please continue to post any relevant information in relation to this topic so it can be addressed at a later time.
Emet.
Emet_Amazon
Hello @MFG23,
I appreciate the additional information, I have also heard back on that follow up review.
If you can escalate this case and see what happens I really appreciate it.
As mentioned I have heard back on the information reviewed. Currently the review team has requested that you provide proper photos of all the 6 sides of the product packaging and the device name as it appears in the manufacturer's device listing.
I would suggest ensuring that the product listing is also updated prior to providing the images in your appeal in the account health page. The review team has asked that you submit this information through the typical means of appeal.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
