The Food and Drug Administration set an ambitious guidance schedule for itself this year. On January 20, the Center for Devices and Radiological Health (CDRH) published two guidances—one on medical device accessories and the other on low risk or “general wellness” devices. This article walks through the general wellness guidance, in which FDA provides many examples of devices they consider to be low risk general wellness products. The guidance, which spends a lot of time on general health and fitness mobile apps, makes clear FDA does not intend to regulate such products.
Products classified as “medical devices” either need to be approved by FDA through pre-market approval or show that they are substantially equivalent to an existing device. Both processes take time and resources, so avoiding the designation is in a company’s best interest. Thus, FDA’s guidance on whether a product is a “general wellness product” instead of a medical device is a very useful document.
FDA states that a general wellness product 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 first category of general wellness intended uses involves claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions. Such claims can relate to diet, fitness, or improving concentration for example, but must not focus on specific diseases.
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General Wellness Claim |
Not a General Wellness Claim |
| Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals | A claim that a product will treat or diagnose obesity
A claim that a product will treat an eating disorder, such as anorexia
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| Claims to promote relaxation or manage stress without reference to anxiety disorders or other reference to a disease or condition
Claims to increase, improve, or enhance the flow of qi
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A claim that a product helps treat anxiety
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| Claims to improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination |
A claim that a computer game will diagnose or treat autism
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| 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
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A claim to restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball
A claim that a product will treat muscle atrophy or erectile dysfunction |
| Claims to promote sleep management, such as to track sleep trends
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| Claims to promote self-esteem, such as to boost self-esteem |
The second category of general wellness claims allows for mention of particular diseases where a product is intended to help achieve a healthy lifestyle. For example, a product that helps track fitness goals may be promoted as helping to reduce the risk of heart disease. FDA states that these claims should only reference a disease where it is well understood in the medical community that healthy lifestyle choices may reduce the risk or impact of a medical condition. 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.
Even certain claims that meet the “general wellness” standards described above will not extend to devices that present inherent risks to a user’s safety. The following attributes of a product present inherent risks, according to FDA:
- Invasive products, such as implants promoted for improved self-image
- Products that involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants–examples include sunlamp products.
- Raises novel questions of usability; or
- Raises questions of biocompatibility.
FDA notes that while certain products, such as laser technology for skin rejuvenation may indeed improve confidence (a general wellness claim), the inherent risks keep the products under FDA oversight.
FDA’s Examples of Low Risk General Wellness Products
(1) A mobile application plays music to “soothe and relax” an individual
and to “manage stress,” where claims relate only to stress management, not to medical conditions.
(2) 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.” FDA makes an important statement here: “To the extent the monitoring or recording exercise activities present risks (such as inaccuracy), when made in the absence of disease or medical condition claims, the risks to the user’s safety are low. Therefore, this product meets both criteria for a low risk general wellness product.”
(3) 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”.
(4) A portable product that claims to monitor the pulse rate of users during exercise and hiking.
(5) A product is intended to mechanically exfoliate the face, hands and feet to make the skin smoother and softer.
FDA explains that this claim relates to self-esteem and does not refer to a specific disease or medical condition, and thus is a general wellness claim. The technology for exfoliating the face poses a low risk to the user’s safety as it does not penetrate the stratum corneum, notes FDA. If, however, “the product exfoliates the skin to enhance the delivery of a topically applied product containing one or more active pharmaceutical ingredients through the stratum corneum, the product would present inherent risks to the user’s safety because of its invasive nature.”
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So far, the low-risk general wellness guidance has been looked upon favorably by the medical device industry as providing some clear examples of products that are outside of FDA’s regulatory scope. Especially as more health and fitness related apps come to market, it is good to know that the mere mention of a disease in promotional materials does give FDA automatic authority to regulate it.
Comments regarding this draft are due by April 20, 2015. View General Wellness: Policy for Low Risk Devices here.
View our article on FDA’s medical device accessory guidance here.