Regulatory Classification
General Wellness Product
Nefesh is classified as a General Wellness Product under FDA guidance. It is not a Software as a Medical Device (SaMD) and does not require FDA clearance or CE marking as a medical device.
What This Means
- Nefesh provides body signals as AI context — it does not diagnose, treat, or prevent any medical condition
- The stress score is a behavioral adaptation signal for AI agents, not a clinical measurement
- Nefesh does not provide clinical interpretation, medical recommendations, or health advice
- The output is intended for general wellness and AI UX optimization only
Disclaimer
Every API response includes the disclaimer: "Not a medical device. For contextual AI adaptation only." This must be displayed to end users in any application that surfaces Nefesh data.
Applicable Guidance
- FDA: "General Wellness: Policy for Low Risk Devices" (2019) — products that promote general wellness and present low risk to user safety
- EU MDR: Not classified as a medical device under Regulation (EU) 2017/745 — no intended medical purpose
- HIPAA: Nefesh does not store Protected Health Information (PHI). No BAA required.