The FDA registration review of medical device products was misjudged as requiring a 510K registration certificate, but in fact it did not require a 510K certificate.
Both of my products have been judged as products that require 510K certification, but in the world, my two products are Class I medical devices and are 510K exempt products. Amazon had previously reviewed one of my products due to this issue. After I provided relevant certification materials for FDA registration and 510K exemption, the product was unblocked and sold normally.
But this time my two similar products have been suspended for sale due to the same operation. I have also provided relevant FDA registration and 510K exemption certification materials, but this review has been for a month and a half, and I have been reviewing them during this period. Repeated requests for the same information that has been provided before. I would like to ask if anyone has encountered a similar situation and how to communicate with the Amazon customer service team more efficiently.
The FDA registration review of medical device products was misjudged as requiring a 510K registration certificate, but in fact it did not require a 510K certificate.
Both of my products have been judged as products that require 510K certification, but in the world, my two products are Class I medical devices and are 510K exempt products. Amazon had previously reviewed one of my products due to this issue. After I provided relevant certification materials for FDA registration and 510K exemption, the product was unblocked and sold normally.
But this time my two similar products have been suspended for sale due to the same operation. I have also provided relevant FDA registration and 510K exemption certification materials, but this review has been for a month and a half, and I have been reviewing them during this period. Repeated requests for the same information that has been provided before. I would like to ask if anyone has encountered a similar situation and how to communicate with the Amazon customer service team more efficiently.
2 replies
Danny_Amazon
Hey there @Seller_IesaeL9zgQt5c- thanks for surfacing this situation for us here on forums and I very much apologize for any delay. While reviews of this nature can take some time, they are completed with the safety of customers at the forefront, so we do appreciate your patience as our teams review the relevant materials.
Best regards,
Danny
