Compliance Requirments - FDA Establishment Listing and Device Listings
We are currently selling medical devices (pantyliners) on Amazon in various configurations (e.g., 10 count, 30 count, 60 count, etc.). The FDA Establishment listing and Device Listings have been provided. Please note that the FDA Device Listings do not include every SKU because the FDA does not require this. Some of our SKUs have been approved by Amazon, while one has not—despite being the same exact product with a different count per box.
We have submitted all necessary documentation, including letters from the FDA Establishment, confirming that all products are manufactured at the same facility and are covered under the Device Listing.
@Glenn_Amazon, do you have any advice on this?
Thank you,
The Regulatory Team
Compliance Requirments - FDA Establishment Listing and Device Listings
We are currently selling medical devices (pantyliners) on Amazon in various configurations (e.g., 10 count, 30 count, 60 count, etc.). The FDA Establishment listing and Device Listings have been provided. Please note that the FDA Device Listings do not include every SKU because the FDA does not require this. Some of our SKUs have been approved by Amazon, while one has not—despite being the same exact product with a different count per box.
We have submitted all necessary documentation, including letters from the FDA Establishment, confirming that all products are manufactured at the same facility and are covered under the Device Listing.
@Glenn_Amazon, do you have any advice on this?
Thank you,
The Regulatory Team
3 replies
Cooper_Amazon
Good Evening @Seller_GgMB5TcB9ijBa,
I'd be happy to look into this situation for you.
Could you please share with us the latest CASE ID filed with Selling Partner Support regarding this issue?
If you have not filed a case with Selling Partner Support, please reach out to them and share as much detail as possible such as:
- The ASIN affected by the FDA flag that has not been approved
- Steps you have taken to try and resolve this issue
- Any screenshots that would be help support your case
- Any additional information that Selling Partner Support would find necessary to help you out
Feel free to post the CASE ID in this discussion once you have contacted support so we can follow the case along to the conclusion. Looking forward to hearing from you soon. Hope you have a great rest of the week.
Sincerely, Cooper_Amazon
