AI-enabled device software is no longer assessed at a single regulatory milestone. FDA’s 2025 guidance reflects a shift toward continuous oversight, where performance, safety, and governance must be demonstrated throughout the product lifecycle.
The FDA AI Guidance Interactive Visualizer translates this regulatory evolution into an accessible, visual format. It helps clinical, quality, and regulatory teams understand how ethical foundations, risk management, validation, and post-market monitoring fit together as a coherent regulatory expectation.
Explore regulatory expectations through interactive scenarios.
Follow the AI Lifecycle From Design to Post-Market Use
Assess Regulatory Risk and Decision Points
Interpret Transparency, Performance, and Governance Expectations
The visualizer is built directly on FDA’s 2025 AI guidance for AI-enabled device software functions. Rather than presenting regulatory text in isolation, it uses interactive visuals to demonstrate how principles such as transparency, bias mitigation, cybersecurity, and continuous learning operate together in practice.
By simulating lifecycle events, performance drift, and risk prioritization, the visualizer facilitates a more straightforward interpretation of regulatory intent and enables teams to anticipate oversight expectations before they become compliance issues.
What changes when AI oversight is treated as a lifecycle responsibility?
Explore how continuous monitoring and documented decision-making shape regulatory confidence over time.
The FDA AI Guidance Visualizer is part of Cyntegrity’s eyesON series—a collection of interactive tools designed to make complex regulatory and clinical concepts easier to explore, understand, and discuss.
These visualizers are offered as educational resources, helping clinical research and regulatory professionals build shared understanding around evolving expectations without adding operational burden. Explore More Interactive Visualizers…
See how other datasets can sharpen signal awareness and decision-making.
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