HOW TO READ DATA
The FDA AI Guidance 2025 Interactive Visualizer distils the agency's 2025 recommendations for AI/ML-enabled device software functions into an interactive storyline that clarifies regulatory expectations. Rather than plotting third-party statistics, each widget interprets the guidance narrative so product, quality, and regulatory teams can translate policy language into day-to-day decisions.
Every section is anchored in the terminology and themes from the 2025 guidance package and associated FDA discussion materials. Use the visuals as a companion while reading the publication:
Colour cues remain consistent: deep blue denotes enduring GxP foundations, orange highlights forward-looking AI governance themes, and green signals adaptive, risk-based practices. Whenever percentages appear, they are illustrative weightings derived from the emphasis placed in the guidance text—not external operational data.
Source: U.S. Food and Drug Administration. FDA AI Guidance 2025: AI/ML-Enabled Device Software Functions, January 2025. All interpretations within the visualiser reference this publication and supporting FDA briefing materials curated by Cyntegrity.
Every section is anchored in the terminology and themes from the 2025 guidance package and associated FDA discussion materials. Use the visuals as a companion while reading the publication:
- Strategic pillars and principles: The hero banner, Total Product Lifecycle loop, and core principles grid condense the guidance's emphasis on transparency, governance, and continuous learning.
- Risk governance matrix: The interactive likelihood-versus-severity grid mirrors how the guidance frames proportional risk controls, allowing quick calibration of mitigation priority.
- Lifecycle monitoring widgets: The drift simulator, update pathway tree, and regulatory decision flow translate post-market expectations into simple, traceable action steps.
- Data stewardship visuals: Representativeness bars, cybersecurity threat panels, and the compliance checklist highlight the dataset quality, security posture, and documentation rigor the FDA looks for in submissions.
- XAI spotlight: The explainability showcase illustrates how sponsors can evidence clinical relevance and user trust when describing AI focus areas to reviewers.
Colour cues remain consistent: deep blue denotes enduring GxP foundations, orange highlights forward-looking AI governance themes, and green signals adaptive, risk-based practices. Whenever percentages appear, they are illustrative weightings derived from the emphasis placed in the guidance text—not external operational data.
Source: U.S. Food and Drug Administration. FDA AI Guidance 2025: AI/ML-Enabled Device Software Functions, January 2025. All interpretations within the visualiser reference this publication and supporting FDA briefing materials curated by Cyntegrity.
