New FDA Draft Guidance for AI-Enabled Medical Devices

By Luca Bogoni, PhD, Founder & Principal, HealthTech Strategies

November 28, 2025

In early 2025 the FDA released a new draft guidance designed to help developers build safer, more transparent, and more reliable AI-enabled medical devices FDA Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices. As AI continues to transform imaging, diagnostics, monitoring, and clinical decision support, the agency is aiming to ensure that innovation is supported by strong safeguards and clear expectations across the full device lifecycle.

The draft guidance lays out practical recommendations for designing, validating, deploying, and maintaining AI-driven technologies. It places particular emphasis on transparency, mitigation of algorithmic bias, robust documentation, and proactive risk management—especially as learning algorithms may evolve after deployment. The document also aligns with the FDA’s recent final guidance on Predetermined Change Control Plans (PCCPs), signaling the agency’s focus on managing postmarket updates and ongoing performance monitoring.

Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, highlighted that the draft consolidates insights from the more than 1,000 AI-enabled devices already authorized in the U.S. He described it as a “first point-of-reference” for developers seeking clarity from the earliest stages of design through real-world use.

The FDA encourages early engagement from industry, positioning this draft guidance as a roadmap to accelerate responsible development and help ensure that AI technologies entering the market deliver safe, effective, and trustworthy patient care.