Need Help: Struggling with Class II Medical Device FDA Approval Process
Hello everyone,
I am an Amazon seller currently facing issues with the FDA approval process for electric breast pumps, which are classified as Class II medical devices. I am hoping to find some help or advice here.
Recently, our product was suspended from sale due to not having an FDA 510(k) clearance. Following Amazon's requirements, we submitted all necessary documents for appeal, including photos of the product packaging, the user manual, and the FDA's 510(k) clearance code. After Amazon requested an English version of the invoice, we obtained an English-formal invoice from our supplier, since the Chinese government issues only electronic invoices in Chinese.
Although Amazon informed us that our FDA appeal was successful and that the product detail page would be restored within two business days, the page was still not restored after two days. Upon contacting Amazon again, they told us that our product page contained false or misleading FDA certification claims. We immediately removed all information regarding FDA approval and had our supplier replace the product packaging images, but Amazon still has not reinstated our product page.
At this point, I am extremely confused and helpless. I do not know what else I can do to meet Amazon's requirements. Has anyone here experienced something similar, or does anyone with relevant expertise have any advice? Any suggestions or experiences on how to navigate the FDA approval process would be greatly appreciated.
Thank you all!
Need Help: Struggling with Class II Medical Device FDA Approval Process
Hello everyone,
I am an Amazon seller currently facing issues with the FDA approval process for electric breast pumps, which are classified as Class II medical devices. I am hoping to find some help or advice here.
Recently, our product was suspended from sale due to not having an FDA 510(k) clearance. Following Amazon's requirements, we submitted all necessary documents for appeal, including photos of the product packaging, the user manual, and the FDA's 510(k) clearance code. After Amazon requested an English version of the invoice, we obtained an English-formal invoice from our supplier, since the Chinese government issues only electronic invoices in Chinese.
Although Amazon informed us that our FDA appeal was successful and that the product detail page would be restored within two business days, the page was still not restored after two days. Upon contacting Amazon again, they told us that our product page contained false or misleading FDA certification claims. We immediately removed all information regarding FDA approval and had our supplier replace the product packaging images, but Amazon still has not reinstated our product page.
At this point, I am extremely confused and helpless. I do not know what else I can do to meet Amazon's requirements. Has anyone here experienced something similar, or does anyone with relevant expertise have any advice? Any suggestions or experiences on how to navigate the FDA approval process would be greatly appreciated.
Thank you all!
1 reply
LeviDylan_Amazon
Hello @Seller_M8ngXAXQ2OmDN,
Thank you for reaching out here on the Seller Forums.
I see that you have received a restricted product policy violation for an item that is considered a class II medical device that has not been 510(k) cleared by the FDA, and you have questions about how to address and resolve this.
As it has been a few days since your post, what is the most recent update about this case? Has the review team asked for any additional information for you to provide? So that I am able to assist you the best, can you share the relevant case log here in this thread, so we can take a look?
I look forward to learning more about your situation. Once you have reviewed the questions above, please feel free to respond here for further guidance. The Forums community and I are here to support you.
Wishing you the best,
LeviDylan
