Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
SaMD risk categories intended medical purpose (horizontal) vs targeted healthcare condition (vertical).
| State of healthcare situation or condition | Significance of information provided by SaMD to the healthcare decision |
||
|---|---|---|---|
| Treat or diagnose | Drive clinical management | Inform clinical management | |
| Critical | IV | III | II |
| Serious | III | II | I |
| Nonserious | II | I | I |
