Life Sciences attorney Christin Carey breaks down the FDA's evolving framework for AI-enabled software as a medical device (SaMD) and what it means for your product roadmap. From the December 2024 PCCP final guidance to the January 2025 lifecycle management draft guidance, Christin walks through the three pillars shaping how manufacturers must think about AI-enabled devices: predetermined change control plans, lifecycle management, and transparency obligations. If your product uses AI or machine learning, the regulatory expectations around post-market changes, bias analysis, and user transparency are already here. Christin outlines the steps companies should be taking now to stay ahead.

FDA in Five: What the FDA's AI-Enabled SaMD Framework Means for Your Product Roadmap