{"entity":{"id":"samd","kind":"term","name":"Software as a medical device (SaMD)","aka":["software as a medical device","SaMD","AI as a medical device","AI/ML-enabled medical device","medical device software"],"tldr":"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.","asOf":"2026-09-24","links":[{"label":"FDA: Software as a Medical Device (SaMD)","url":"https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd"},{"label":"Wikipedia: medical software","url":"https://en.wikipedia.org/wiki/Medical_software"}],"tags":["cansim-terms"],"related":["fda-oce","cancer-ai-vocabulary"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["research-use-only","analytical-vs-clinical-validation","model-card"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"provenance":{"editedBy":"OnCo CanSim terms wave (Wikipedia summaries, standards and project pages, GDC and FDA pages, Europe PMC)","editedOn":"2026-09-24","note":"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"},"category":"Regulation & policy"},"route":"/terms/samd/","neighbours":{"institution":[{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"}],"term":[{"id":"analytical-vs-clinical-validation","kind":"term","name":"Analytical versus clinical validation","route":"/terms/analytical-vs-clinical-validation/"},{"id":"cancer-ai-vocabulary","kind":"term","name":"Cancer AI vocabulary (CanSim terms map)","route":"/terms/cancer-ai-vocabulary/"},{"id":"model-card","kind":"term","name":"Model cards and datasheets for datasets","route":"/terms/model-card/"},{"id":"research-use-only","kind":"term","name":"Research use only (RUO)","route":"/terms/research-use-only/"}]}}