MDLinx January 19, 2026
By Elizabeth Pratt | Fact-checked by Davi Sherman

Industry Buzz

The current rule changes are intended to affect only low-risk software and devices designated as general wellness products. However, what qualifies as low-risk and a general wellness product is open to interpretation.

—David Cutler, MD

The FDA’s new guidance on general wellness products has sparked debate among experts about how much oversight is warranted.

Some argue that easing regulations on general wellness products poses risks, while others argue that the new guidance makes sense.

“Even with additional clarifying language, there has often been uncertainty about which products truly require FDA review and which do not. By more clearly delineating a category of low-risk ‘general wellness’ products,...

Today's Sponsors

Venturous
ZeOmega

Today's Sponsor

Venturous

Continue Reading

 
Topics: Digital Health, FDA, Govt Agencies, Physician, Provider, Technology
Related Articles:
AI Model FDA-Cleared to Triage 14 Conditions
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 2)
FDA Updates Two Digital Health Final Guidance Documents
FDA in Flux — January 2026 Newsletter
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1)

Share Article