EU AI Act vs FDA SaMD Compliance: 7 Critical Wins
Let me be direct: EU AI Act vs FDA SaMD compliance is the most consequential dual-regulatory challenge facing digital health startups right now. Not eventually. Right now, in 2026, with the AI Act’s high-risk provisions fully operative. FDA’s Predetermined Change Control Plan (PCCP) guidance is simultaneously reshaping how machine-learning-enabled devices are reviewed on the US … Read more