The US Food and Drug Administration (FDA) recently issued a draft guidance document announcing that it does not intend to regulate low-risk products intended for general wellness only as medical devices. The draft document guidance, titled “General Wellness: Policy for Low Risk Devices – Draft Guidance for Industry and Food and Drug Administration Staff,” follows a recent trend by the FDA to decrease regulation of low-risk devices marketed for non-therapeutic use.
The guidance describes a “general wellness product” as one that relates to maintaining, or encouraging, a healthy lifestyle. According to the draft guidance, general wellness products may include exercise equipment, audio recordings, video games, software programs, and similar types of products that are generally available at retail stores.
The draft guidance identifies two types of general wellness devices that are low risk — those that do not make any reference to diseases or conditions, and those that promote healthy lifestyle choices which could positively impact users living with a specific disease or condition.
The guidance provides the following examples of wellness claims that do not necessarily specify a disease or condition:
- Weight management;
- Physical fitness (e.g., 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.
The guidance provides the following examples of wellness claims that specify a disease or condition, but only in the context of reducing risk associated with the disease or condition, or that promote healthy a lifestyle to improve living with the disease or condition:
- 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; and
- 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 guidance also provides the following examples of mobile medical applications (MMAs) that are promoted as low-risk general wellness products:
- A MMA that plays music to “sooth and relax” an individual and to “manage stress”;
- A MMA 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”; and
- A MMA that 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.”
In addition, the draft guidance includes a “decision algorithm” (i.e., a decision tree flow chart) that can be used to help determine whether a product falls within the low-risk category of wellness products exempt from regulation under the FD&C Act.