FDA Clarifies Regulatory Pathways for AI-Driven Stress Management Apps
The U.S. Food and Drug Administration has issued clarifications on how digital tools that manage stress fit into…
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Federal drug and device approvals, safety alerts, and regulatory guidance.
FDA Issues New Recommendations for Software-Based Mental Health Treatments
The U.S. Food and Drug Administration released updated guidance on digital health technologies for mental health…
Read More →FDA Issues Draft Guidance on Software as a Medical Device for Mental Health Apps
The U.S. Food and Drug Administration updated its regulatory framework for software as a medical device that targets…
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