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

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 June 17, 2026? - How does a Predetermined Change Control Plan (PCCP) streamline post-market updates? - What specific device types fall under this new Class II regulation? - What are the "special controls" manufacturers must now implement? - How does this change affect the regulatory strategy for AI-based medical devices? - What steps should your QMS team take to prepare for a PCCP submission? - Are there specific labeling requirements under this new final order? - How can companies leverage this new pathway for faster market access? Sources: - https://www.federalregister.gov/documents/2026/06/17/2026-12166/medical-devices-radiology-devices-classification-of-the-radiological-machine-learning-based - https://www.fda.gov/about-fda/cdrh-new-news-and-updates/cdrh-new-news-and-updates How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex requirements like the FDA's new AI software classification. Our experts develop efficient regulatory strategies, create robust technical dossiers, and manage submissions to authorities worldwide. By combining local expertise with advanced AI tools, we streamline global market access, helping you get your products to patients faster. For support with your FDA submission, PCCP development, or global expansion, contact us at [email protected] or visit https://pureglobal.com. Explore our free AI tools and global device database at https://pureglobal.ai.