Lexology January 22, 2026
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FDA Loosens Digital Health Enforcement Policies

What is happening: FDA Commissioner Dr. Marty Makary announced on January 6, 2026 at the Consumer Electronics Show and on social media that the agency was creating new policies to relax regulatory enforcement for certain digital health products. That same day, FDA released revised guidances on clinical decision support (CDS) software and general wellness products. Significant changes include:

1. Clinical Decision Support Software Guidance

  • Expanded FDA’s interpretation of Criterion 3 from Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for determining whether a CDS software function is exempt from device regulations. The agency will now exercise enforcement discretion for CDS software functions that output a single preventive, diagnostic,...

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Topics: FDA, Govt Agencies
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