United States | Regulatory Framework
Status: in force
Effective: 2026-01-06
high FDA final guidance on clinical decision support software (Jan 2026)
Clinical Decision Support Software — Guidance for Industry and Food and Drug Administration Staff (January 2026)
I. Regulatory Summary
Materially affects product classification and regulatory strategy for AI-enabled CDS. Advisory teams should update scoping analyses, clinician transparency materials, validation documentation, and change-control governance.
II. Full Description
Sources: [{“name”: “U.S. Food and Drug Administration (FDA)”, “url”: “https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software”, “lang”: “en”}, {“name”: “U.S. Food and Drug Administration (FDA)”, “url”: “https://www.fda.gov/media/109618/download”, “lang”: “en”}, {“name”: “American Hospital Association (AHA)”, “url”: “https://www.aha.org/news/headline/2026-01-06-fda-issues-guidance-wellness-products-clinical-decision-support-software”, “lang”: “en”}, {“name”: “Healthcare Dive (Industry Dive)”, “url”: “https://www.healthcaredive.com/news/fda-exempts-wearable-ai-features-guidance/809102/”, “lang”: “en”}]
III. Scope & Application
Final FDA guidance clarifying when clinical decision support (CDS) software functions are excluded from the definition of a medical device and when they remain regulated. It emphasizes transparency and independent reviewability, affecting AI/ML-enabled analytics and certain generative-AI features used in clinical workflows.
IV. Policy Impact Assessment
Materially affects product classification and regulatory strategy for AI-enabled CDS. Advisory teams should update scoping analyses, clinician transparency materials, validation documentation, and change-control governance.
Primary Focus: ai medical software classification