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.
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.
2 replies
Seller_iSwFsh8mpukKZ
Anyone knows that or anyone can share your experience?
Cooper_Amazon
Good Evening @Seller_iSwFsh8mpukKZ,
If you want to get all the testing done for each color and submit it all in one report, that works as long as the partner team can match that information to your detail page (all the information you gave Amazon about your product in the first place). You may also need to submit photos of your product, so please make sure all the information is included when you are submitting compliance information.
-->HERE<-- is a great post about what to expect when submitting compliance documents and best practices. Please let us know if we can help you with any other questions.
Have a lovely rest of your week and thank you for patiently waiting for a response.
Sincerely, Cooper_Amazon
