FDA Adopts a Laissez-Faire Stance on AI Devices and Software
Endpoint Security, Standards, Regulations & Compliance Agency: Guidance Prioritizes Market Innovation Over Federal Oversight Marianne Kolbasuk McGee (HealthInfoSec) • January 7, 2026 The U.S. Food and Drug Administration announces that certain AI-enabled “low-risk” health devices and clinical decision support software will not undergo regulatory scrutiny (Image: FDA). The U.S. Food…