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Are there FDA requirements for non-device clinical decision support software?

Anonymous · Published March 12, 2026 · 1 comment
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 still specific FDA requirements, or is it entirely outside the scope of FDA regulation?

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Anonymous 2 months ago
Check if other US laws, such as those related to privacy, might still apply even if FDA requirements do not.
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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
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 meet to enter the US market. However, keep in mind that other regulations, such as privacy laws, may still apply depending on how your software handles data or interacts with users.

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