ClinicScribeCompare
Independent · Vendor-neutralNo paid inclusion, placement, or scoreSix-dimension rubric11 scribes tracked300-visit evaluation corpusVerified January 01, 1970Vol. II · No. 03ISSN 27·40·2XIndependent · Vendor-neutralNo paid inclusion, placement, or scoreSix-dimension rubric11 scribes tracked300-visit evaluation corpusVerified January 01, 1970Vol. II · No. 03ISSN 27·40·2X
Glossary

FDA Software as a Medical Device (SaMD)

Regulatory category for software that itself is a medical device.

The FDA classifies software as a medical device when its intended use is diagnosis, treatment, prevention, mitigation, or cure. Ambient documentation is generally outside SaMD scope; CDS features that drive diagnosis or treatment can pull an AI scribe into it.