Scope and date
Reviewed 13 October 2026. This guide concerns selected FDA sources for devices and device software functions. It does not cover foods, dietary supplements, drugs, biologics, cosmetics or combination products, and it does not decide the status of an individual product.
1. Describe every function
Record the product, hardware and software configuration, intended users, setting, inputs, outputs and every statement about what the function does. Separate an activity or wellness feature from any function concerned with diagnosis, cure, mitigation, prevention or treatment.
2. Check the device starting point
FDA's How to Determine if Your Product is a Medical Device explains the agency's starting route and directs products outside the device definition to other FDA centres where applicable. Use the current source rather than a copied definition.
3. Read the current general-wellness guidance
FDA issued the final General Wellness: Policy for Low Risk Devices in January 2026. The page states that it concerns low-risk products promoting a healthy lifestyle and does not apply to products regulated by other FDA centres. The guidance is non-binding and does not establish that a product has been shown safe or effective for its intended use.
4. For software, follow the function
FDA's Digital Health Policy Navigator step on healthy-lifestyle functions distinguishes functions unrelated to disease from other functions and points readers back to the general-wellness policy. Assess each function rather than assigning one label to an entire application.
Record the reading
| Item | Record |
|---|---|
| Function and exact statement | |
| Product/configuration | |
| Official source and URL | |
| Issuer, date and status | |
| Passage considered | |
| Why it may apply | |
| Facts or questions still unresolved |
Check FDA's live pages for revisions before relying on the guide. For an individual regulatory decision, use the route provided by the responsible authority or obtain qualified advice.