U.S. Food and Drug Administration (FDA): Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD) in healthcare refers to software applications that are intended to be used as medical devices. These software applications are designed to diagnose, treat, or monitor medical conditions and are subject to regulatory oversight by government agencies such as the US Food and Drug Administration (FDA). Examples of SaMD include telemedicine applications, mobile health apps, and artificial intelligence algorithms used in medical imaging and diagnosis. In order to be classified as a SaMD, the software must meet certain criteria, such as having a intended medical use, being intended for use in the diagnosis, treatment, or prevention of a disease or condition, and being classified as a medical device by the relevant regulatory body. The regulatory oversight of SaMD is designed to ensure the safety and effectiveness of these software applications in healthcare, and to protect patients from potential harm.