Update – Clinical Decision Support Software Final Guidance

A one page summary to clarify guidance on determining when CDS software is excluded from the definition of a “medical device” under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Only software functions that meet all four specified criteria qualify as “Non-Device CDS” and therefore are not subject to FDA device regulation. If any criterion is not met, the software may be regulated as a medical device.

Download