Here we go again now surgical kits

This product was flagged

Get the usual form letter, send all the information which creates a problem because they want a 510K code which the item is exempt from that code because IT ISN’T SURGICAL

The only reason I am fighting this is because of the ding to my account health because of this, but once again banging my head into a wall

the letter

Hello ,

We received your appeal for the ASINs B000P76A0W , but we are unable to reactivate your ASINs at this time.

What actions do I need to take?
To reactivate your ASINs, send the following documentation and information:

– Photos of all the sides of the product packaging.
– Photos of the instructions included with the product.
– The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product.

Additionally, if the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), then also provide the following:
– 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.

If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.

Food and Drug Administration (FDA) resources
To learn more about the Food and Drug Administration (FDA) requirements, you can go to the following pages:
– “How to Determine if Your Product is a Medical Device”:
How to Determine if Your Product is a Medical Device | FDA
– “510(k) Clearances”:
510(k) Clearances | FDA
– “Device Registration and Listing”:
Device Registration and Listing | FDA
– “Who Must Register, List and Pay the Fee”:
Who Must Register, List and Pay the Fee | FDA

How do I send the required information?
You can provide the required information on your “Account Health” page by clicking the appeal button next to the deactivated listing and following the instructions provided:
https://sellercentral.amazon.com/performance/dashboard?ref=ah_em_rp

What happens if I do not provide the required information?
If we do not receive a response, the listing will remain deactivated. The violation record will remain on your “Account Health” page for up to 180 days after the listing was deactivated or until the violation is successfully disputed. Deleting your listing on this ASIN does not sufficiently address the reason for the violation and will not result in its removal from your “Account Health” page. Leaving this and other listing violations unaddressed may result in account deactivation. Within 90 days from the listings deactivation, if you do not provide the required information, you will receive a request to remove the inventory associated with these listings per our removal policy. Failure to address this request can lead to destruction of your inventory. For more information on our removal policy, go to “Required removals”:
https://sellercentral.amazon.com/gp/help/external/202000820?referral=A93E46868I8DD_A18KQVW6YDLZD1&referral=A93E46868I8DD_A1JB6WVN4DG1M3

We’re here to help
For more information on Medical Devices, go to “Medical devices and accessories”:
https://sellercentral.amazon.com/help/hub/reference/external/200164650

Amazon Services

Thank you for selling with Amazon,

Lohitha H.
Amazon.com Seller Support

Explanation as to why it is exempt

Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
© intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).

The item does not meet any of these clasifications.

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20 days later finally won.
I had to do the check list of how I provided everything by copying and pasting their letter and the explanations

What we have here is a failure to communicate.

I have provided all the information you have requested, Yet you keep sending the same useless form letter over and over again without stating what you actually need.

Photos of all the sides of the product packaging. - Provided
Photos of the instructions included with the product - Provided
The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product. - There is none they are not surgical instruments covered by 510(k)

If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption. - Provided including links to the FDA website showing they are exempt as the items included are not surgical items. obtained from the links you provided

Could someone that will actually look at the information provided work on this case and not someone that will send the same form letter for the 6th time.

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