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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.
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.
Shares Model cards and datasheets for datasets, Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Model cards and datasheets for datasets, Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Model cards and datasheets for datasets, Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Analytical versus clinical validation, Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Analytical versus clinical validation, Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.
Shares Cancer AI vocabulary (CanSim terms map) and the tag cansim-terms.