Step 3: Is the Software Function Intended For Maintaining or Encouraging a Healthy Lifestyle?
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?
LIKELY NOT A DEVICE
WHY: Section 520(o)(1)(B) of the FD&C Act excludes software functions that are intended "for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition" from the device definition under section 201(h) of the FD&C Act. Considering your answers to the previous questions, answering "Yes" to Question 3.A suggests that the software function may not meet the device definition.
If you are unsure, go to Question 3.B to learn about other device criteria and considerations that may apply to your software function.
LEARN: General Wellness: Policy for Low Risk Devices (see Section III. for examples of software functions that involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Continue to Question 3.B.
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?
Continue to Question 3.C.
The General Wellness: Policy for Low Risk Devices recommends that disease-related general wellness claims should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by health care professional organizations.
Your product may be a device. Go to Step 4.
WHY: Answering "No" to Question 3.B suggests that the software function is likely NOT a low risk general wellness product and is likely outside the scope of the General Wellness: Policy for Low Risk Devices. The software function may be the focus of the FDA's regulatory oversight as a device.
LEARN: General Wellness: Policy for Low-Risk Devices
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
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?
Continue to Question 3.D.
Some general wellness intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. Such intended uses are described in the General Wellness: Policy for Low Risk Devices as representing the relationship between healthy lifestyle and disease as "may help to reduce the risk of" or "may help living well with" a chronic disease or condition.
Your product may be a device. Go to Step 4.
WHY: Statements other than "may help to reduce the risk of" or "may help living well with" a chronic disease or condition are beyond the scope of FDA's policy that is described in General Wellness: Policy for Low Risk Devices. Answering "No" to Question 3.C suggests that the software function is likely NOT a low risk general wellness product. The software function may be the focus of the FDA's regulatory oversight as a device.
LEARN: General Wellness: Policy for Low-Risk Devices
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
3.D: Is the software function low risk?
LIKELY FDA INTENDS TO EXERCISE ENFORCEMENT DISCRETION
WHY: If the product is not invasive, is not implanted, and does not involve a technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure, it is generally considered low risk. In answering this question, consider whether CDRH regulates products of the same type as the product in question by using the Medical Device Databases. Whether a device is classified as class I under section 513(a)(1) of the FD&C Act does not necessarily mean that it is "low risk" for purposes of the General Wellness: Policy for Low Risk Devices. Considering your answers to the previous questions, answering "Yes" to Question 3.D suggests the software function is likely a general wellness product within the scope of the General Wellness: Policy for Low Risk Devices and may fall within FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time).
If you are unsure, go to Step 4 to learn about other device criteria and considerations that may apply to your software function.
LEARN: General Wellness: Policy for Low-Risk Devices
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Your product may be a device. Go to Step 4.
WHY: Only low risk products are within the scope of FDA's enforcement discretion policy described in General Wellness: Policy for Low Risk Devices. Answering "No" to Question 3.D suggests that the software function is likely NOT a low risk general wellness product. The software function may be the focus of the FDA's regulatory oversight as a device.
LEARN: General Wellness: Policy for Low-Risk Devices
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
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