The draft does not classify memorial clones as medical devices, but recommends informed consent flows, age gating, and built-in routing to mental-health resources when distress signals appear in a conversation.
Regulation · April 30, 2026
FDA Issues Draft Guidance on Grief-Care AI Clones
The Food and Drug Administration's draft framework treats AI clones built to comfort the bereaved as wellness products with conditions on safety, escalation, and clinical evidence.