FDA final guidance on general wellness and low-risk devices (Jan 2026)

General Wellness: Policy for Low Risk Devices — Guidance for Industry and Food and Drug Administration Staff (January 2026)

I. Regulatory Summary

Requires legal and advisory teams to reassess claims, labeling, and governance for AI-enabled wellness features. Can reduce regulatory burden for properly scoped wellness analytics but increases risk where marketing drifts into diagnostic/treatment claims.

II. Full Description

Sources: [{“name”: “U.S. Food and Drug Administration (FDA)”, “url”: “https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices”, “lang”: “en”}, {“name”: “U.S. Food and Drug Administration (FDA)”, “url”: “https://www.fda.gov/media/90652/download”, “lang”: “en”}, {“name”: “Reuters”, “url”: “https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-limit-regulation-health-fitness-wearables-commissioner-says-2026-01-07/”, “lang”: “en”}, {“name”: “Healthcare Dive (Industry Dive)”, “url”: “https://www.healthcaredive.com/news/fda-exempts-wearable-ai-features-guidance/809102/”, “lang”: “en”}]

III. Scope & Application

Final FDA guidance describing its enforcement policy for low-risk ‘general wellness’ products and software functions. It clarifies claim and risk boundaries relevant to AI/ML-enabled wellness measurements and analytics, affecting classification, labeling, and regulatory strategy for digital health products.

IV. Policy Impact Assessment

Primary Focus: medical device ai oversight