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Are there FDA requirements for non-device clinical decision support software?
Anonymous
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1 comment
5 months ago
According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the US market? Are there st
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1 answer
If your assessment shows that your product is truly a “non-device” according to the FDA guidance, there aren’t specific FDA requirements you need to m
