Day: January 8, 2026

Clinical decision support software now sits squarely at the intersection of digital innovation and device regulation. With its January 6, 2026 update, FDA has materially refined the boundary conditions for when CDS functions are excluded from device status under the FD&C Act. For sponsors, developers, and regulatory strategists, the guidance signals a tightening of expectations … Read more

As digital health technologies continue to proliferate, regulatory boundary setting has become increasingly critical. FDA’s 2026 update to its General Wellness policy refines the Agency’s enforcement posture for low-risk products. For regulatory professionals, this guidance provides essential insight into FDA’s current interpretation of device scope and risk. On January 6, 2026, the U.S. Food and … Read more