# Software as a medical device (SaMD)

Source: https://onco.cc/terms/samd/  
OnCo record `samd` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Software as a medical device is software that is itself the medical device, such as a program that predicts a diagnosis or a treatment response, and is regulated like one.

## Summary

The FDA's Digital Health Center of Excellence page defines software as a medical device, following the International Medical Device Regulators Forum, as software intended for a medical purpose that performs that purpose without being part of a hardware device, and lists examples and its clinical decision support policy. A prognostic or drug-response model used to guide a patient's care would be SaMD and would need clearance or approval, with analytical and clinical validation and a plan for updates; a research model carries a research-only notice instead.

## Fields

- Kind: Term
- Last checked: 2026-09-24
- Also known as: software as a medical device; SaMD; AI as a medical device; AI/ML-enabled medical device; medical device software
- Tags: cansim-terms

## Notes

- Listed in the CanSim terms map 1.0.0 (docs/onco/terms.json, generated 2026-09-24), CC BY 4.0, attribution: CanSim project, an open, public-data-first cancer foundation-model programme; CanSim page path /terms/samd.

## Sources

- FDA: Software as a Medical Device (SaMD): https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
- Wikipedia: medical software: https://en.wikipedia.org/wiki/Medical_software

## Connected records

- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/)
- terms: [Analytical versus clinical validation](https://onco.cc/terms/analytical-vs-clinical-validation/), [Cancer AI vocabulary (CanSim terms map)](https://onco.cc/terms/cancer-ai-vocabulary/), [Model cards and datasheets for datasets](https://onco.cc/terms/model-card/), [Research use only (RUO)](https://onco.cc/terms/research-use-only/)

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JSON: https://onco.cc/api/v1/entities/samd.json