Help Needed: Amazon Listing Issues with FDA Classification
Hi Amazon Community,
I’m reaching out because I need help resolving an issue with my product listing that has been causing significant frustration and financial loss for my company.
Background:
Ten days ago, my product was identified as an impression material and classified as a Class 2 device, requiring FDA registration and a 510(k) number. In response, I uploaded the necessary documents, including our supplier's FDA registration and 510(k) exemption documents, along with our company's purchase orders showing our brand sourcing from them.
Despite providing clear evidence that our product is 510(k) exempt, Amazon keeps responding with the same generic message stating that the evidence is insufficient. It feels like I'm dealing with a robot.
Actions Taken:
1. Uploaded supplier’s FDA registration and 510(k) exemption documents.
2. Provided purchase orders as proof of sourcing.
3. Submitted additional documentation showing that impression material is Class 1, not Class 2, according to the FDA website.
4. Contacted customer support via phone multiple times but received no helpful resolution.
Product Details:
We sell custom night guards designed to prevent teeth grinding. The impression material in question is merely a tool used in the process of making these night guards and should be classified as a Class 1 device.
Current Situation:
My product listing has been disabled for ten days, causing significant financial losses.
I believe the evidence provided fully supports that our product is not a Class 2 medical device.
Customer support has been unable to offer any solutions or escalate the issue.
Request for Help:
Can a live support representative please intervene and assist in resolving this issue? I need my listing to be reactivated as soon as possible. The continued disablement of my listing is severely impacting my business.
Help Needed: Amazon Listing Issues with FDA Classification
Hi Amazon Community,
I’m reaching out because I need help resolving an issue with my product listing that has been causing significant frustration and financial loss for my company.
Background:
Ten days ago, my product was identified as an impression material and classified as a Class 2 device, requiring FDA registration and a 510(k) number. In response, I uploaded the necessary documents, including our supplier's FDA registration and 510(k) exemption documents, along with our company's purchase orders showing our brand sourcing from them.
Despite providing clear evidence that our product is 510(k) exempt, Amazon keeps responding with the same generic message stating that the evidence is insufficient. It feels like I'm dealing with a robot.
Actions Taken:
1. Uploaded supplier’s FDA registration and 510(k) exemption documents.
2. Provided purchase orders as proof of sourcing.
3. Submitted additional documentation showing that impression material is Class 1, not Class 2, according to the FDA website.
4. Contacted customer support via phone multiple times but received no helpful resolution.
Product Details:
We sell custom night guards designed to prevent teeth grinding. The impression material in question is merely a tool used in the process of making these night guards and should be classified as a Class 1 device.
Current Situation:
My product listing has been disabled for ten days, causing significant financial losses.
I believe the evidence provided fully supports that our product is not a Class 2 medical device.
Customer support has been unable to offer any solutions or escalate the issue.
Request for Help:
Can a live support representative please intervene and assist in resolving this issue? I need my listing to be reactivated as soon as possible. The continued disablement of my listing is severely impacting my business.
0 respuestas
Stevie_Amazon
Hi there @Seller_Q1ZUrkJIKU3sN,
Thank you so much for posting here in the Forums! I apologize for the time it has taken for me to reply here.
I understand you have recently received a restricted products violation for an item you have listed for sale, which has been identified as a medical device.
There are certain requirements that must be met for these items permitted for sale on Amazon.
"Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product."
What information is on your listing? Are you accurately describing the item?
1. Uploaded supplier’s FDA registration and 510(k) exemption documents.
2. Provided purchase orders as proof of sourcing.
3. Submitted additional documentation showing that impression material is Class 1, not Class 2, according to the FDA website.
Did you provide the requested documentation in its entirety? You will want to provide not only the FDA registration and 501(k) exemption but also the photos of the product from all sides and copies of the instructions in addition to the exemption number?
Without adequate proof that this violation is an error, we are unable to guarantee the reactivation of your listing.
If so, please do not hesitate to provide any case IDs where this submission was made and I will look it over.
All the best,
Stevie.
