On July 29, 2016, the FDA released a final guidance on “General Wellness: Policy for Low Risk Devices,” approximately 18 months after first proposing a novel rationale for not regulating what might otherwise be considered medical devices.
The guidance specifies that products “likely” won’t be regulated as medical devices if (1) they are “low risk” (i.e. are not implanted or invasive or may pose a risk if specific regulatory controls are not applied such as for laser products) and (2) are intended only for “general wellness” use.
There are two broad categories of “general wellness” products. First are those that relate to maintaining or encouraging a general state of health or a healthy activity that do not refer to any specific disease or condition. The FDA enumerated seven specific areas that are apparently exhaustive and not merely examples of this category, namely: (1) weight management; (2) physical fitness/recreation; (3) relaxation or stress management; (4) mental acuity; (5) self-esteem; (6) sleep management; and (7) sexual function. Examples of such a product include a pulse rate monitor for use during exercise and an exfoliator to make skin smoother and softer.
The second category of “general wellness” products are those that are intended to promote, track, and/or encourage choices which, as part of a healthy lifestyle, may help to either (1) reduce the risk of certain chronic diseases or conditions or (2) live well with certain chronic diseases or conditions. Such wellness claims may only be made where it is “well understood” that healthy lifestyle choices may reduce the risk or impact of a chronic disease or conditions, such as may be evidenced by peer-reviewed scientific publications or official statements from healthcare professional organizations. Examples of such a product include a mobile app that reminds users to minimize exposure to the sun (which may reduce the risk of skin cancer) and a mobile app that monitors and records workout activity to maintain good cardiovascular health.
The FDA’s approach for this second category is similar to the agency’s regulation of “structure/function” claims for dietary supplements, which must be substantiated with valid scientific evidence but do not require prior FDA approval. Such claims typically refer to maintaining healthy structure or function of the body or general well-being. Thus, reference to the FDA’s dietary supplement regulations may help to inform how the agency will implement the new “general wellness” policy for low risk devices.
The final guidance is available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf.