AI-Enabled Medical Device Software Functions: FDA Guidance

This FDA guidance offers recommendations for manufacturers regarding marketing submissions for medical devices incorporating artificial intelligence (AI). It outlines a total product lifecycle (TPLC) approach, emphasizing transparency and addressing potential biases in AI-enabled devices. The guidance details necessary documentation and information for FDA review, covering device description, user interface, risk assessment, data management, model development, validation, cybersecurity, and public submission summaries. Appendices provide further insights into transparency design, performance validation, usability, and model card examples. The document aims to promote safe, effective, and high-quality AI-enabled medical devices by aligning with software-related consensus standards and encouraging ongoing performance monitoring. The core focus is assisting manufacturers in meeting regulatory expectations and ensuring device safety and effectiveness through comprehensive documentation and adherence to best practices.