The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including certain wearable devices) and the other related to clinical decision support software. The guidance on low-risk wellness products clarifies the FDA’s interpretation of a provision within section 520 of the Food, Drug and Cosmetics Act, which states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not considered a device under the law. Guidance would apply to low-risk “general wellness products” designed to encourage a general state of health or healthy activity or products that are intended to relate the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic conditions, where it is understood that healthy lifestyle choices may play an important role in health outcomes for a condition.
The clinical decision support software guidance clarifies the FDA’s interpretation of a separate provision within section 520 of the Food, Drug and Cosmetics Act. Specifically, the guidance is intended to clarify the types of clinical decision support software functions that are excluded from the definition of “device” by the four criteria identified in the law. It provides examples of how the FDA intends to consider clinical decision support software functions as non-device functions, medical device functions and device functions subject to FDA enforcement discretion.
