FDA Releases Draft Guidance on Lifecycle Management for AI-Enabled Device Software Functions

The FDA draft guidance for Artificial Intelligence-Enabled Device Software Functions (AI-DSFs) offers comprehensive recommendations to manufacturers on lifecycle management, transparency, and bias mitigation. Emphasizing a Total Product Life Cycle (TPLC) approach, the guidance ensures AI-enabled devices meet regulatory standards, maintain safety, and address the needs of diverse patient demographics, including race, ethnicity, sex, and age. By adopting FDA-recognized consensus standards and implementing strategies to manage AI-related risks, manufacturers can enhance the quality and effectiveness of their devices. Early engagement with the FDA for combination products that integrate AI-DSFs is encouraged, fostering compliance and innovation in medical device development.