SaMD

Software as a Medical Device (SaMD)

Global: International Medical Device Regulators Forum (IMDRF) – The term Software as a Medical Device is defined  as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” (Source: International Medical Device Regulators Forum (IMDRF) – Key Definitions, Dec 2013).

FDA, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) considers medical purpose as those purposes that are intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions (Source: FDA website – Software as a Medical Device (SaMD)).