FDA AI Medical Device Guidance 2026: New Rules for Transparency and Lifecycle Management

Medical Device Global Market Access · Jun 14, 2026 · 5m

This episode breaks down the US FDA's new draft guidance on AI-enabled medical device software, released on June 6, 2026. We explore the FDA's stricter requirements for algorithm transparency, data provenance, risk management, and real-world performance monitoring. We discuss how these changes impact pre-market submissions and post-market obligations for manufacturers and highlight the critical opportunity to provide feedback before the public comment period closes on August 5, 2026. Key Questions: - What are the four key areas of change in the FDA's 2026 AI medical device guidance? - How…