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  4. Step 3: Is the Software Function Intended For Maintaining or Encouraging a Healthy Lifestyle?
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Step 3: Is the Software Function Intended For Maintaining or Encouraging a Healthy Lifestyle?

Digital Health Policy Navigator - Step 3

Software functions intended for maintaining or encouraging a healthy lifestyle unrelated to a disease or condition are excluded from the device definition under section 520(o) of the FD&C Act. Some general wellness products may be devices if they promote a healthy lifestyle and also relate to reducing the risk or impact of certain chronic diseases or conditions. For low risk products that promote a healthy lifestyle (general wellness products), FDA does not intend at this time to examine whether they are devices, or if they are devices, whether they comply with device requirements.

Step 3 will help determine:

  • If your software function that is intended for maintaining or encouraging a healthy lifestyle is considered a device; or
  • If your software function is a low risk general wellness product that is not the focus of the FDA's regulatory oversight.

3.A: Is the software function intended for maintaining or encouraging a healthy lifestyle AND is UNRELATED to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition?

3.B: Does the software function have an intended use that relates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions?

3.C: Is the relation between healthy lifestyle and disease specifically expressed as "may help to reduce the risk of" or "may help living well with" a chronic disease or condition?

3.D: Is the software function low risk?

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