FDA Revises Regulatory Framework for Software-Based Mental Health Treatments
The U.S. Food and Drug Administration has updated its guidelines for the regulatory review and approval of digital…
Read More →Policy & Explainers
Legislation, oversight, and evergreen explainers grounded in primary documents.
FDA Clarifies Oversight for Digital Tools Used in Stress Management and Mindful Movement
FDA Policy Distinguishes Regulated Devices From Low-Risk Wellness Tools for Stress and Activity
Read More →Key Findings from Cochrane Reviews and NIH Sources on Tai Chi, Yoga and Stress in Aging Populations
National Center for Complementary and Integrative Health summaries review dozens of randomized trials on yoga, tai chi…
Read More →FDA Outlines Regulatory Pathways for Prescription Digital Tools in Stress Management
The FDA evaluates certain digital tools for stress management as medical devices when they make claims about treating…
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