FDA clarifies the line between Clinical Decision Support (CDS) software and regulated Software as a Medical Device (SaMD).

As AI-enabled healthcare software continues to evolve, understanding where FDA draws the regulatory boundary has never been more important.

The FDA's Clinical Decision Support Software FAQs reinforce a few key principles:

• Not all CDS software is a medical device.
• To fall outside FDA's device definition, a software function must meet all statutory criteria, including enabling healthcare professionals to independently review the basis for its recommendations.
• Software that analyzes medical images or signals, replaces clinical judgement, or does not provide sufficient transparency is more likely to be regulated as a medical device.

For developers, this isn't simply a software design question – it's a regulatory strategy decision that can significantly influence your product's development pathway, evidence requirements and time to market.

If you're developing AI-enabled or decision support software, it's worth reviewing your intended use, functionality and user interaction early in development to determine whether your product is likely to be considered Non-Device CDS or regulated SaMD.

Have you assessed whether your software still fits within FDA's interpretation of Non-Device CDS?

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