FDA Clarifies Standards for Clinical Validation of Artificial Intelligence in Medical Software
The U.S. Food and Drug Administration has issued updated guidance on the validation of artificial intelligence and…
Read More →FDA & Regulation
Federal drug and device approvals, safety alerts, and regulatory guidance.
FDA Expands Criteria for Digital Mental Health Product Approvals
The FDA released updated draft guidance in December 2023 that outlines expectations for digital therapeutics aimed at…
Read More →FDA Issues New Framework for Real-World Evidence on Digital Mental Health Tools
The U.S. Food and Drug Administration has released updated guidance that allows sponsors to submit real-world data and…
Read More →FDA Modernizes Framework for Software-Based Mental Health Treatments
The U.S. Food and Drug Administration released draft guidance in September 2023 that updates how software products…
Read More →FDA Outlines Regulatory Expectations for Digital Tools Targeting Behavioral Health and Mindfulness
The FDA applies its existing policies to software that claims effects on behavioral health or mindfulness. Tools…
Read More →FDA Outlines When Digital Tools for Stress Management and Mindful Movement Qualify as Medical Devices
FDA Draft Guidance Clarifies When Digital Health Technologies for Stress and Physical Activity Qualify as Medical…
Read More →FDA Clarifies Evidence Standards for Digital Tools Marketed to Support Stress Management and Mindful Movement
FDA Draft Guidance Clarifies Oversight of Digital Therapeutics for Stress and Anxiety
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