Overview
Software as a Medical Device (SaMD) is software that performs a medical function on its own – diagnosing, monitoring, or informing a treatment decision – without being part of a physical device. If an app’s output could reasonably change a clinical decision, the FDA can classify it as SaMD and regulate it accordingly, separately from ordinary wellness or scheduling apps.
Why it matters
Misjudging whether a product counts as SaMD is a costly mistake to make late – it changes the entire development process, from documentation and risk classification to whether FDA clearance is required before launch at all. A telehealth or diagnostic-adjacent feature added without checking this can stall a launch by months.
How Dotcode applies it
We flag SaMD risk early in scoping for telehealth and clinical-decision features, so regulatory classification is a planning input, not a launch-week discovery.
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