The way consumers access and interact with health information has changed exponentially over the past few years thanks to rapid innovation in health IT.  Mobile medical application developers and other health and wellness product manufacturers have struggled to understand how their rapidly evolving technology fits within the existing regulatory framework, and have been pressing for specific guidance. 

As 2015 began, the Food and Drug Administration offered two draft guidance documents aimed at these industry concerns: General Wellness: Policy for Low Risk Devices, January 16, 2015 (General Wellness Draft Guidance) and Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory TypesJanuary 20, 2015 (Medical Device Accessories Draft Guidance).  With these draft guidance documents, FDA indicates that it will not take enforcement action in connection with low-risk general wellness products and establishes a new risk-based approach to medical device accessories − a relevant development for many health IT offerings.

General Wellness Draft Guidance: Will FDA regulate my wellness-related technology?

Products oriented toward “general health and wellness” have long presented uncertainty for the industry.  This is in large part because the definition of “device,” which triggers FDA oversight, leaves significant room for interpretation.  A key criterion to being considered a “device” under the Food, Drug, and Cosmetic Act (FD&C Act) is whether the item is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man … or intended to affect the structure or any function of the body of man....”

Many companies developing general health and wellness products have questioned whether they would be regulated by FDA.  Absent seeking a formal determination from the agency (not always a desirable approach, especially early in product development), companies were left to interpret limited FDA enforcement precedent and informal policy statements on the topic, or potentially seek non-binding informal guidance.  This created an environment with little predictability.

Examples of general health and wellness products that FDA previously indicated it would not actively regulate include:

  • Exercise equipment intended only for general physical conditioning or for the development of athletic abilities in individuals who lack physical impairment
  • More recently, certain categories of health-related mobile apps, such as those that provide educational resources, reminders, or motivational guidance; and those that help consumers track information and encourage positive behaviors like healthy eating and exercise.

Although FDA’s recent discussion of mobile apps lent some previously-lacking clarity, in the General Wellness Draft Guidance FDA offers guiding principles that can be applied to a variety of products, a “decision algorithm” as a tool for companies to use in evaluating a specific product, and more precise and current examples and guidelines for the industry.

FDA’s draft guidance indicates that it will not pursue enforcement action against “low risk general wellness products,” reducing uncertainty for companies whose products fall within the boundaries of the guidance.

FDA defines “general wellness products” as:

[P]roducts that (1) are intended for only general wellness use, as defined in this guidance, and (2) present a very low risk to users’ safety. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), provided these two criteria are met.

Further, according to FDA, a “general wellness product” falls into one of two categories, and either:

[H]as (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. 

FDA explains that to fall within the first category, the product must not make any reference to diseases or conditions.  So, for example, FDA would consider a claim relating to “weight management” − for the promotion or maintenance of a healthy weight, encouraging healthy eating or assisting with weight loss goals − to be a general wellness claim.  In contrast, FDA states that a claim that a product “will treat or diagnose obesity” does not fall into the category of a general wellness claim. 

FDA offers other contrasting examples, including relaxation or stress management vs. the treatment of anxiety; and claims to enhance or improve sexual performance vs. a claim that a product will treat muscle atrophy or erectile dysfunction.

FDA’s second category includes products intended to:

  • promote, track and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic disease or conditions and
  • promote, track and/or encourage choice(s) which, as part of a healthy lifestyle,  may help living well with certain chronic diseases or conditions.

FDA offers several examples of verbiage for such a claim, for example: “Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.”

FDA provides a number of illustrative examples of products it would consider to be low risk general wellness products, including mobile medical apps that:

  • Play music to “soothe and relax” an individual and to “manage stress”
  • Solely monitor and record daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health”
  • Monitor and record food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity."

Medical Device Accessories Draft Guidance: How will FDA evaluate the risks of my technology? 

FDA’s Medical Device Accessories Draft Guidance clarifies and modifies the agency’s policy concerning the classification of accessories and discusses the application of that policy to specific categories of devices that are commonly used as accessories to other medical devices. 

This guidance is of particular relevance to developers and manufacturers of apps and other technologies that connect − whether physically or through the cloud − to “parent” platforms or products that are considered medical devices.  FDA will deem apps and technologies to be “medical device accessories” if they are intended to support, supplement, or augment the performance of the parent medical device.

Historically, FDA has classified accessories by either grouping them with the parent device − for example, a parent device is subject to 510(k), so accessories must also follow the 510(k) process)  −  or by specifically addressing a particular accessory through its own classification regulation.

In contrast, FDA now proposes regulating medical device accessories based on the risks they present when used with their parent devices - not based on the parent device's risks

Thus, FDA acknowledged that some device accessories may have lower associated risks than their parent devices, and thus warrant different levels of regulation. 

For companies seeking to market what they believe to be a lower-risk accessory of a new type – not previously classified under the FD&C Act, nor approved in an application for premarket approval (PMA) − FDA encourages use of the de novo classification process.  This process provides the potential for such an accessory to be placed into Class I or Class II, as opposed to defaulting to Class III classification with its more stringent requirements. 

Of course, whether the de novo pathway is ultimately a viable way to obtain a lower classification for a particular device or accessory will depend on various factors influencing the product’s risk profile.