As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days.
"A general wellness product, for the purposes of this guidance, has (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 guidance explains.
"Where it is well understood" is an important turn of phrase here. When does a particular wellness activity's contribution to the prevention of a specific disease or condition become "well understood"? That may be up to the lawyers to decide, but when it does, wellness device and app makers can use it in the marketing materials.
The document goes on to outline two different categories for general wellness devices that fall outside of FDA regulation.
The first group of devices are those that "do not make any reference to diseases or conditions" and instead make claims that are more general. On their own, 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" are not going to move a device into a regulated category.
The second group of general wellness devices outlined by the FDA are those that do make reference to specific diseases or conditions, but only do so in two specific ways. They either claim to help users reduce the risk of certain diseases or conditions or they may help users better live with specific diseases or conditions. The FDA explains:
"Both subcategories of disease-related general wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are typically described in peer-reviewed scientific publications. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes."
The FDA also provides some helpful examples for the various types of claims that general wellness devices can make and still remain outside of their regulatory purview. Here are just a few:
Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals.
Claims to promote relaxation or manage stress when there is no reference to anxiety disorders or other reference to a disease or condition.
Claims to increase, improve, or enhance the flow of qi.
Claims to improve mental acuity, instruction following, concentration, problemsolving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination.
Claims to promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy.
Claims to promote sleep management, such as to track sleep trends.
Claims to promote self-esteem, such as to boost self-esteem.
And:
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.
As always, there are a number of caveats. All the above may be true, but the device must also be considered "low risk", which means it can't be break or pierce the skin or otherwise be invasive; it can't involve an intervention or technology that may pose a risk to the user's safety if controls are not applied (lasers, radiation, implants); it can't raise novel questions of usability; and it can't raise questions of biocompatibility.
The FDA also included examples of claims that general wellness device makers should not use if they are aiming to remain unregulated. Here are a few:
A claim that a product will treat or diagnose obesity;
A claim that a product will treat an eating disorder, such as anorexia;
A claim that a product helps treat anxiety;
A claim that a computer game will diagnose or treat autism;
Some of the FDA's examples in the draft guidance for general wellness devices that are "low risk" were mobile apps:
A mobile application plays music to “soothe and relax” an individual and to “manage stress.”
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”.
Read the full FDA draft guidance on general wellness devices here. We'll update this post with more analysis as it comes in.
