Edge Compliance’s response to FDA’s GenAI discussion paper. Our core message is that hallucination is inevitable whatever a product’s intended use, so a common safety baseline should apply to all GenAI that can give health advice. Above that baseline, regulation should scale to intended use and risk through existing pathways, with a stronger postmarket focus and international alignment. Done well, and with HCPs equipped to use it, GenAI can close long-standing care gaps, notably in women’s health, rather than deepen them.