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FDA General Wellness Framework

U.S. Food and Drug Administration. General Wellness: Policy for Low Risk Devices, 2023.

Key provisions used in wiki

  • Permits peer support and general wellness guidance without requiring FDA device clearance, provided claims are limited to general wellness
  • Draws the regulatory floor: wellness tools that do not diagnose, treat, cure, or prevent disease fall outside FDA device jurisdiction
  • Defines the boundary between permissible wellness functions (stress management, healthy lifestyle) and regulated clinical functions
  • Directly informs InvisibleBench scope-creep scenarios that test whether AI systems stay within wellness framing and avoid clinical claims
  • Establishes the safe harbor that GiveCare's Mira operates within: peer support and wellness guidance, not clinical treatment