FDA Clarifies When Software & Wellness Products Are Not Medical Devices

AGG Life Sciences attorneys Alan Minsk and Aditya Krishnaswamy co-authored an article for Medical Device and Diagnostic Industry (“MD+DI”) discussing the FDA’s revised guidance that provides clarity on when low-risk wellness products and clinical decision software classify as medical devices.

For clinical decision software, intended use determines whether software supports or replaces clinical judgment. For wellness products, intended use determines whether the product stays within the low-risk framework or triggers device oversight. However, classifying a product incorrectly can mean costly delays, unexpected premarket submissions, and enforcement risk.

Manufacturers should treat intended use as a design constraint from the outset and ensure all user-facing messaging aligns with the desired regulatory classification.

“The revised guidance, expanded examples, and new real-world evidence pathways give manufacturers a stronger foundation for early-stage regulatory assessments,” said Alan and Aditya. “Companies that align product design, intended use claims, and validation strategies with these frameworks can reduce classification uncertainty and accelerate time to market.”

To view the full article, please click here.