SaMD Classification and Regulatory Pathway: A Quick-Reference Summary

SaMD Classification and Regulatory Pathway, in Brief

If you are building software that diagnoses, treats, monitors, or manages a disease or condition, you are likely developing a Software as a Medical Device (SaMD) — and the classification you land on determines your entire regulatory pathway, timeline, and evidence burden. This page is a quick-reference summary; for the full framework, read on below.

FDA aligns with the International Medical Device Regulators Forum (IMDRF) definition: SaMD is software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device. The 21st Century Cures Act excludes certain functions — administrative support, general wellness, electronic health records, and specific clinical decision support software — from that definition entirely; everything else is evaluated under IMDRF's risk framework (significance of information × state of the healthcare situation), which maps to FDA's Class I/II/III structure and, from there, to a 510(k), De Novo, or PMA pathway.

For the complete classification walkthrough — the Cures Act exclusions, the IMDRF risk matrix, and what each device class means for your submission — see our full SaMD classification framework guide. If your product uses AI or machine learning, classification is only the starting point: PCCP scope, GMLP, and adaptive-vs-locked algorithm strategy follow directly from it, covered in our AI/ML SaMD regulatory strategy guide.