Summary
Final FDA guidance clarifying which clinical decision support software functions are excluded from the definition of a medical device under the 21st Century Cures Act and which functions remain subject to FDA medical-device oversight, with examples addressing different CDS functions and user relationships.
Healthcare Implications
Shapes the regulatory treatment of clinical AI and decision-support products by clarifying when software falls outside FDA device jurisdiction and when developers must satisfy medical-device requirements. Developers, providers, and health systems should use the guidance when classifying CDS functions, designing transparency for clinical users, and planning regulatory strategy.