The FDA released new guidance on “General Wellness: Policy for Low Risk Devices guidance” (January 2026) which offers apt and much-needed clarity on how the agency interprets and applies its regulations to “general wellness” devices or software. General wellness devices or software are products intended to support or promote a healthy lifestyle, rather than to diagnose, treat, cure, mitigate, or prevent a specific disease or condition. Cited examples include:
- “Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals;
- Claims to promote relaxation or manage stress;
- Claims to increase, improve, or enhance the flow of qi “energy””
These are in juxtaposition to devices or software that remain FDA regulated – for example:
- “A claim that a product helps treat an anxiety disorder;
- A claim that a computer game will diagnose or treat autism;…
- A claim to restore a structure or function impaired due to a disease or condition, e.g., a claim that a prosthetic device enables amputees to walk”
The guidance can help researchers and IRBs better understand when FDA regulation does — and does not — apply. What ultimately drives FDA oversight is not the physical object or software itself (both of which can be “devices”), but how it is intended to be used and the claims being evaluated in the study. Accordingly, the aims of the research, the population studied, and the outcomes being assessed are central to determining whether an activity falls within general wellness or crosses into regulated medical device research.
Find the new FDA guidance here: