Software as a Medical Device (SaMD)

Also known as: SaMD

Software intended for a medical purpose that performs that purpose without being part of a hardware medical device.

Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes, such as diagnosis, monitoring, or treatment support, that performs that purpose without being part of a hardware medical device. Most standalone clinical AI diagnostic and decision-support tools fall under this category.

Related Terms

FDA Clearance (510(k)) Clinical Decision Support (CDS)

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