FDA CDRH provides regulatory guidance for artificial intelligence-enabled medical devices, addressing the unique oversight considerations for AI/machine learning-based Software as a Medical Device (SaMD). The resource covers quality management systems, validation methodologies, performance monitoring, and cybersecurity requirements aligned with IEC 62304 standards. It serves as a reference document for manufacturers developing AI-integrated medical devices authorized for U.S. marketing, emphasizing transparency, safety evaluation, and ongoing post-market surveillance protocols.

The FDA has updated its comprehensive searchable databases of medical devices incorporating digital health technologies authorized for U.S. marketing. These updated lists encompass artificial intelligence and machine learning-enabled devices, augmented and virtual reality medical devices, and sensor-based digital health technology solutions. This resource provides manufacturers, healthcare professionals, and regulatory stakeholders transparent access to cleared and approved AI/digital health-integrated medical devices, supporting informed decision-making and regulatory compliance efforts while facilitating continued innovation in the digital health medical device sector.

The FDA CDRH issued final guidance on human factors information for medical device marketing submissions, establishing a risk-based framework applicable to 510(k) premarket notifications, De Novo requests, premarket approval applications (PMAs), and humanitarian device exemption (HDEs). The guidance clarifies expectations for human factors documentation, enabling manufacturers to provide appropriately scaled submissions based on device risk. By streamlining requirements, the guidance reduces regulatory burden while maintaining submission quality and ensuring proper risk mitigation in device design and usability.

This final guidance document assists sponsors and other stakeholders in collecting, validating, and integrating patient preference information (PPI) to support regulatory decision-making across the complete product lifecycle. The document specifies methodological approaches to study design, data validation, and strategic incorporation of PPI throughout development, premarket review, and post-market phases. A reference document for demonstrating patient-centered evidence in device submissions.