Medical Devices and Accessories

Medical devices are regulated by the Food and Drug Administration (FDA), which is the U.S. federal agency that is responsible for ensuring that medical devices intended for human use are safe and effective. A medical device is an instrument, apparatus, machine or related object used to diagnose, cure, treat, or prevent diseases in people or animals. Medical devices can also be used to change the structure or function of the body, such as stimulating hair growth.[1]

To get more information about Medical Devices, see this article.

At a Glance

Restricted Product Policy Violations Details:

The violation details are located under “Reason” in Restricted Product Policy Violations in Account Health Performance. The details are very specific for each yank reason. The following are just 2 out of many yank reasons:

This product has been identified as a microneedling skin roller or similar product that is considered a medical device due to either (1) the product’s technical characteristics, as the product’s needle length is greater than 0.3 mm, (2) the inclusion of medical marketing claims in the product details and/or images, or (3) a combination of both technical characteristics and marketing claims.
This product has been identified as a pulse oximeter, which is a professional-use only medical device. 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 (1) upload photos of all sides of the product packaging to the product detail page, (2) upload photos of the instructions for use included with the product to the product detail page, and (3) provide the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. 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), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page (https://sellercentral.amazon.com/gp/help/external/help.html?itemID=200164650&language=en-US&ref=efph_200164650_cont_200164330) and the following FDA guidance: https://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm

How to Fix?

Document the changes/actions you will take.

The best way fixing a medical device yank is providing counterarguments against the yank reason. You need to prove that Amazon claims aren’t visible from the product’s (a) description, (b) instruction and (c) label.

Needful Things:

Photos of all sides of the product packaging (just the packaging)
Instructions/Manual for use included with the product (PDF format)
510(k) number issued by the U.S. Food & Drug Administration (FDA) if the seller is participating in the Professional Health Care Program (thus, optional but I bet most of the sellers don’t have it).

Actions:

Let’s use the first case/yank reason on this file (microneedling):

Description - The reason states that the only allowed microneedling without a certificate is less than 0.3 mm in length of the needles. Thus, make sure that there is no 0.3 mm or higher in the title, bullet points, description, A+ content, and search terms. Put the correct length of the needles as proof that the length is shorter than 0.3 mm, thus, a good counter argument against the yank reason. Same principle applies to all. It’s best to do the changes through a feed file to obtain the batch ID.
Instructions/Manual - The product specifications are further explained and further proof of noprohibited medical claims present.

Product Manual should be uploaded in Product Documents. Please follow this pathway Inventory > Manage Product Documents > Upload New Document > Fill out the necessary fields > for Document type, select either User Guide, User Manual, or Application Guide.

Note (April 1, 2022):

I found out that you cannot add the product manual if the listing is yanked but you need to check if there’s an existing document. If not, then add it once the listing gets reinstated.

Include the Instructions/Manual to the case (if it wasn’t resolved on the initial appeal).

If you’re confident that everything is set, go to Performance > Account Health > Restricted Product Policy Violations > Look for the ASIN > Appeal > Check the 2 boxes and Submit. Wait 24 hours before the listing gets reinstated.

What if the listing remained yanked?

Send a ticket. Follow this pathway Help > Get Support > Selling on Amazon > Or, browse for your issue in the menu > Products, Listings, or Inventory > Inventory file upload issue.
Title/Reason: “US - Restricted Products - Appeal - ASIN: B0xx”
Body (the following is just an example, please don’t copy but tweak it depending on the actions you took).

Greetings,

We're sorry that you yanked ASIN B095X7B324 because you identified it as a microneedling skin roller.

We want to appeal that this item is a toiletry travel bag and it doesn't have any microneedling terms in its description or keywords. Also, we have uploaded the instructions manual of this product in Product Documents. Please see that the specifications show that the length of the needles are 0.22mm shorter than 0.3 mm that is against your medical devices policy.

I have attached the photos of all sides of the packaging for you to review.

Please reinstate the listing. Send this to the internal team for further review and reinstatement.

Get the case ID and monitor the updates.

Useful Tool:

FDA Establishment Registration & Device Listing

https://sellercentral.amazon.com/help/hub/reference/G200164650 ↑