SaMD
Also known as: Software as a Medical Device, Digital Medicine, AI/ML Medical Software
Software as a Medical Device — software that performs a medical function independent of any hardware device it runs on.
Full Definition
SaMD is regulated by the FDA under a framework that classifies software based on the significance of the information it provides and the state of the healthcare situation it addresses. SaMD includes clinical decision support software, AI/ML diagnostic algorithms, and digital therapeutics that meet the definition of a medical device. The regulatory pathway for SaMD is distinct from traditional device pathways and continues to evolve as FDA develops new guidance.
Example
An AI algorithm that analyzes retinal images and diagnoses diabetic retinopathy without physician interpretation is SaMD. An algorithm that flags images for physician review may or may not be SaMD depending on its intended use and the degree of physician oversight.