On January 20, 2015, the FDA issued draft guidelines^[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.

In publishing the guidance, the FDA sets forth the scope of the category for general  wellness products as those products that have “(1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”

The FDA indicates that it does not intend to regulate low risk general wellness products, but clarifies that the products must be intended only for general wellness use (as defined in the guidance).  The guidance categorizes the types of general wellness devices that are “low risk” as either (i) those that “do not make any reference to diseases or conditions” and instead make claims that are more general such as claims related to “weight management, physical fitness, including products intended for recreational use, relaxation or stress management, mental acuity, self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem), sleep management, or sexual function” or (ii) those that may reference a specific disease or condition but in relation to reduction of risk of certain diseases or conditions or to assist a user to lead a better life with a specific disease.

The FDA also provides some helpful examples of the types of claims that general wellness devices can make and still remain outside of the scope of regulatory oversight.  For example:

• Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.

• Software Product Y tracks your caloric intake and helps you manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type 2 diabetes.

• Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.

The FDA also did not overlook the prevalence of mobile applications relating to general wellness.  The guidance included a few examples of mobile applications that would be considered low risk.

• A mobile application that solely monitors and records daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health.”

• A mobile application monitors and records food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity”.

While the FDA provides some helpful examples of the various types of claims that a general wellness device can make and still remain outside of the scope of regulatory review, there are provisions in the draft guidance open for interpretation such as what may be considered “well understood and accepted that healthy lifestyles choices may play an important role in health outcome.”  In addition, developers should be mindful of the fact that even if a product makes claims relating to general wellness, if the product is invasive or involves an intervention or risk of safe if the device is controls are not applied (like lasers or implants), the FDA would seek to regulate such a product.

_{[1]  Draft Guidance for Industry and Food and Drug Administration Staff}