Table. Risk Profiles as Defined in the 21st Century Cures Act for Software as Medical Device Ranging From Low Risk (Class I) to High Risk (Class IV) .

State of Healthcare Situation or Condition	Significance of Information Provided by SaMD to Healthcare Decision
	Treat or Diagnose	Drive Clinical Management	Inform Clinical Management
Critical	IV	III	II
Serious	III	II	I
Non-serious	II	I	I

Abbreviation: SaMD, software as medical device.

Source: US Food & Drug Administration.⁸