Urgent Assistance Needed: Amazon Product Removal Over Alleged Medical Device Violation FDA&510K(Case ID 14556009911)
This item has been determined to be an Intense Pulse Lamp Hair Removal System, which is a medical device for professional use only. According to Amazon policy, only medical devices intended for professional use may be sold to healthcare buyers who have an Amazon Business Buying account and are licensed accordingly. If you believe this determination is incorrect and your item is not a medical device intended for professional use only, please contact the seller or vendor support with the following information: (1) a photo of all sides of the item's packaging, (2) a photo of the instruction manual that accompanies the item, and (3) the 510(k) code issued by the U.S. Food and Drug Administration for the item. If the trade name on the product packaging, instruction manual, or ASIN detail page does not match the name of the device as provided in the 510(k), in addition to the information above, you will need to provide the following information: (1) the device manufacturer's U.S. Food and Drug Administration registration or owner or operator number, (2) the name of the device as it appears in the manufacturer's trade information for the device, and (3) a copy of the manufacturer's 510(k) code indicating that the device was purchased from the manufacturer. (3) the order form, invoice, or supporting letter (in English) from the manufacturer indicating that the device was purchased from the manufacturer.
We have provided the information as requested by Amazon but have been denied. I'm not sure exactly what to do next. I desperately need help, thank you very much!
Urgent Assistance Needed: Amazon Product Removal Over Alleged Medical Device Violation FDA&510K(Case ID 14556009911)
This item has been determined to be an Intense Pulse Lamp Hair Removal System, which is a medical device for professional use only. According to Amazon policy, only medical devices intended for professional use may be sold to healthcare buyers who have an Amazon Business Buying account and are licensed accordingly. If you believe this determination is incorrect and your item is not a medical device intended for professional use only, please contact the seller or vendor support with the following information: (1) a photo of all sides of the item's packaging, (2) a photo of the instruction manual that accompanies the item, and (3) the 510(k) code issued by the U.S. Food and Drug Administration for the item. If the trade name on the product packaging, instruction manual, or ASIN detail page does not match the name of the device as provided in the 510(k), in addition to the information above, you will need to provide the following information: (1) the device manufacturer's U.S. Food and Drug Administration registration or owner or operator number, (2) the name of the device as it appears in the manufacturer's trade information for the device, and (3) a copy of the manufacturer's 510(k) code indicating that the device was purchased from the manufacturer. (3) the order form, invoice, or supporting letter (in English) from the manufacturer indicating that the device was purchased from the manufacturer.
We have provided the information as requested by Amazon but have been denied. I'm not sure exactly what to do next. I desperately need help, thank you very much!
3 Antworten
Stevie_Amazon
Hi there @Seller_PDe93Yga7hYbO,
I appreciate you for utilizing the Forums and providing this insight into your situation.
Per Amazon's medical devices and accessories policy, "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." This will include any listing, item, or packaging which makes medical claims or alludes to being a medical device.
Per the case ID you provided in your title, Case ID 14556009911, the documents you have provided are showing that this is an over-the-counter item.
"Some medical devices may be sold over-the-counter (OTC) to general consumers, while others are professional use and prescription only (Rx) medical devices. The FDA differentiates medical devices as OTC and Rx by assessing a device intended use and how safe it is to operate the device. FDA makes this differentiation by assessing the potential harm imposed on a patient because of the operation method of a device. Devices that are considered to be potentially harmful or unsafe unless operated under the supervision of a licensed healthcare practitioner are considered to be Rx medical devices. These products must comply with FDA’s Rx labeling requirements and they may only be sold to licensed healthcare practitioners. FDA recognizes that OTC and Rx classification can depend on a manufacturer’s intended use for the device. In these instances, the manufacturer is responsible for determining if the medical device should be sold to the general consumers (OTC) or if it can only be sold and operated by licensed healthcare practitioners (Rx)."
This means the listing must accurately reflect that it is an OTC item in addition to not making medical claims in any way, shape, or form. Please visit this help page for more information such as compliance check lists.
Please continue utilizing this thread and ask further questions, provide further details, or update us on your situation. The Forums community and I are here to support you.
All the best,
Stevie
