FDA Low Risk General Wellness

Identify marketing claim
MEDICAL DEVICE CLAIM
GENERAL WELLNESS PRODUCT
General wellness ONLY
with
NO disease or condition
reference?
Claim reference a disease
or condition ONLY
in a context of
lifestyle?
GENERAL WELLNESS CLAIMS ONLY:
may help reduce risk
OR
may help living well with
AND
ONLY based on
generally accepted science?
Low Risk Technology
Check
Does the claim explicitly or implicitly
reference diagnosis, treatment, prevention,
mitigation, monitoring, or screening of a
disease or condition?
ALL MUST BE NO:
Invasive?
Implanted?
Hazardous tech?
(laser, radiation, stimulation)
Venipuncture / microneedles?
FDA actively regulates product type?
Physiological
parameters
involved?
ALL MUST BE YES:
Wellness-only use?
No clinical thresholds?
No alerts for medical action?
No substitution for FDA-cleared device?
Values valided if mimicking clinical

Is Your Wellness Product a Medical Device?

YES
NO
YES
NO
YES
NO
YES
NO
ALL NO
ANY YES
ANY NO
ALL YES
YES
NO
REF: “General Wellness: Policy for Low Risk Devices” issued on January 6, 2026