Is my health AI a medical device under FDA rules?

In short: If your software analyses patient data to diagnose, treat, monitor, or recommend care, it likely meets the FDA device definition. Exemptions exist for general wellness products and some clinical decision support — but they turn on your claims and the clinician's ability to independently review the basis for recommendations.

FDA's device test, in plain terms

FDA's device definition is broad by design: an instrument, apparatus, or software intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body. For software specifically, what pulls a product into that definition is usually its function — does it analyze data to produce a diagnostic conclusion, a treatment recommendation, or a monitoring alert — rather than the underlying technology. AI doesn't change the test; it changes how scrutinized the "how does it reach that conclusion" question becomes.

The two carve-outs, and why they're narrower than they look

General wellness products that promote a healthy lifestyle without referencing a specific disease can sit outside FDA's active oversight — largely as a matter of enforcement discretion for low-risk products rather than a blanket definitional exclusion — but the moment your claims reference a disease or condition, that policy stops applying, regardless of how the underlying technology works. Clinical decision support software can be exempt under a separate, narrower test with four specific conditions, including that a clinician can independently review the basis for the software's recommendation rather than relying on it as a black box. Opaque AI models that don't expose their reasoning in a clinician-reviewable way usually fail that condition and remain regulated devices — subject to a narrow exception introduced in FDA's January 2026 CDS guidance revision (see the CDS FAQ) — even when the underlying function looks like clinical decision support.

Why this matters before you write another line of marketing copy

Both exemptions turn on claims and design choices you control, which means the same underlying model can be inside or outside FDA's scope depending on how it's built and described. Getting a confident read on this before your product and marketing are locked in avoids the more expensive version of this conversation: discovering the answer during a partnership due-diligence review or an FDA warning letter.

Where next: Does My Health AI Need FDA Clearance? · What is the clinical decision support (CDS) exemption?

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