FDA Seeks Public Comment on Regulatory Framework for Generative AI-Enabled Medical Devices
The FDA’s Center for Devices and Radiological Health (CDRH) has released a discussion paper titled 'Considerations for the Regulation of Generative AI-Enabled Medical Devices,' seeking public feedback on a potential regulatory framework. This paper is not a draft or final guidance but rather an invitation for comments on how to regulate generative artificial intelligence (GenAI)-enabled medical devices. It poses 26 discussion questions across key areas, including risk assessment, a competency-based approach for premarket evaluation, postmarket monitoring, foundation model device master files, and considerations for agentic AI systems. The CDRH is exploring a two-axis risk framework, similar to ISO 14971, which evaluates the activity performed by a GenAI function and the consequences of incorrect outputs. Additionally, a competency-based approach for premarket evaluation, drawing parallels from medical training and licensure, is being considered, involving non-clinical device benchmarking and clinical confi... 
