Our products are classfied as medical device and required to supply label report
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Seller_iSwFsh8mpukKZ

Our products are classfied as medical device and required to supply label report

Our product is classified as a medical device requiring FDA registration. According to Amazon's requirements, we need to provide a lab-generated label compliance report under 21 CFR Part 801. My key question is: If we obtain the report for one product variant, will additional color variations of the same product require separate reports? Despite opening cases, Amazon support has provided no clear guidance, stalling our product launch.

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Seller_iSwFsh8mpukKZ

Anyone knows that or anyone can share your experience?

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