FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices

Medical Device Global Market Access · Jun 19, 2026 · 5m

On June 17, 2026, the US FDA finalized a new Class II classification for radiological machine learning-based quantitative imaging software. This episode breaks down the new rule, explaining how the inclusion of a Predetermined Change Control Plan (PCCP) creates a more streamlined process for future algorithm updates. We detail the specific device types affected and the special controls manufacturers must now implement, offering practical steps for regulatory and quality teams to adapt their strategies. Key Questions: - What is the new FDA classification for AI/ML imaging software announced on…