FDA Guidance on Wellness Products

Technological advances in software and telecommunications, as well as personal function data gathering, have caused uncertainty about what role the Food & Drug Administration may play in regulating products and services designed to improve wellness or fitness.  The FDA has broad regulatory powers over medical devices, which potentially include any device which is using software of some type.  The FDA has released some guidance on mobile apps and similar technology and now releases a final guidance on General Wellness devices, at least ones considered low risk.   (FDA Guidance)   The guidance says that the FDA does not intend to look at “low risk general wellness” products to determine if they meet the definition of a device, essentially excluding such products from any regulatory scrutiny.  So what makes something a “low risk general wellness” product.   The FDA provides its usual crystal clear thinking on the topic.

A general wellness product is one that “has an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or … that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases.”  The product must have solely that purpose.  The first category relates to uses that don’t make reference to diseases, for example claim regarding weight management, physical fitness, relaxation, mental acuity, sleep management, etc.  You cross the line if, however, you claim that the product will treat obesity or an eating disorder, for example.  The second category can have reference to diseases, but only in terms of encouraging activities that limit the risk or impact, not specifically diagnosing or treating the disease.   And in making the claim, there has to be widely accepted evidence that the activity will reduce the risk or impact.  So, for example, it is established that keeping weight under control can limit diabetes risk.  The guidance gives several useful examples.

Once you determine the product is a “general wellness” one, the question is what level of risk is associated with it.  Similar products that are already regulated by the FDA are likely not low risk.  An invasive or implantable product is not low risk.  A product that poses a risk to the safety of users or others is not low risk, examples being lasers or radiation, such as sun lamps, or neurostimulation.  Again, a number of examples are provided of both low and non-low risk products.  General activity trackers are clearly low risk, as are mobile apps that just involve tracking or encouraging certain activities, like diet and exercise.  The guidance should help developers steer clear of regulation if they want to avoid it.