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Dear All,
My question is related to the scope the FDA's guidance - Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions. The guidance states that "Test reports for clinical studies, animal studies, and
studies evaluating the performance characteristics of in vitro diagnostic devices are also excluded from the scope of this document."
The question is that does the bolded wording mean this guidance is not applicable for IVD device at all? I am thinking at least stability study - device shelf-life and life-time studies, shall be conducted following the guidance but not analytical performance studies, system testing and of course all the testing in consensus standards?
Thank you!