Table 2A.

Proposed Classes of Clinical Software Exemptions and Regulation by Category of Software

Type of Software	Description
Class A	Software exempt from FDA regulation; local SOC monitoring optional. (Please refer to definitions of risk categories and regulatory classes in Table 1A,1B.)
Category 0	Informational or generic products
Category 0	Non-clinical systems
	Any system not directly involved in patient care and any system not serving as an integral component of a larger system providing patient care—i.e., systems that do not play any role in suggesting diagnoses, suggesting prognoses, or suggesting or implementing orders or treatments.