FDA-exempt!!!!!! please help
I’m facing a compliance issue with one of my product listings and could really use some advice.
My listing was recently suppressed due to regulatory requirements, and Amazon requested FDA 510(k) clearance for reinstatement.
However, my product falls under an FDA-exempt category , and I’ve already uploaded the necessary documentation to confirm this exemption. Despite submitting this multiple times, I keep receiving the same response asking for a 510(k) number.
Has anyone else faced a similar situation? I’d love to hear any insights on how to clarify exemption status effectively or if there’s a better way to escalate the case for further review. Thanks in advance for any guidance!
0 replies
Glenn_Amazon
Hi there @Seller_UyTjywmzfUq1Z,
I'm sorry you are having difficulties getting your product reinstated. In general issues with 510(K) documentation in my experience can occur if the information you provided on the detail page doesn't match exactly to the information in the 510(K). If you provide your most recent Seller Support Case on this issue and I will see what I can do to escalate. Thank you for your understanding.
-Glenn
