If you’re reading this, you may be one of the hundreds of millions of consumers who downloaded a mobile health app this year to help you keep your New Years’ resolution. You may also be one of the estimated 92% of people who, by the third week of January, have already given up on that goal. Fear not. The Food and Drug Administration (“FDA”) recently issued a draft guidance that may leave a significant number of so-called “mobile medical applications” unregulated, meaning there will potentially be more, and better, apps available to get you back on track.
The guidance, entitled “General Wellness: Policy for Low Risk Devices,” is aimed at providing clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (“general wellness products”). The FDA is careful to mention in the draft that the guidance does not change any requirements of the Food, Drug, and Cosmetic Act (“FD&C Act”) or its applicable regulations.
As I previously reported, the FDA already regulates certain mobile medical applications depending on whether they meet the definition of a medical “device” under Section 201(h) of the FD&C Act. As the FDA has recognized, many mobile apps are not medical devices (meaning they do not meet the definition of a device under section 201(h)), and therefore the FDA does not regulate them. For mobile apps that do meet the definition of a medical device but pose a lower risk to the public, the FDA exercises enforcement discretion over those devices (meaning it does not enforce requirements under the FD&C Act). At the time the FDA released the mobile medical app regulations in September 2013, it acknowledged that the majority of mobile apps on the market fit into these first two categories – but questions remained.
Enter this week’s new draft guidance clarifying which mobile medical applications will not be regulated by the FDA. According to the guidance, the CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act, or, if they are devices, whether they comply with the pre-market review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations. The guidance also notes that it does not apply to products regulated by other FDA Centers.
CDRH defines general wellness products as products that are intended only for general wellness use, and present a very low risk to users’ safety. A general wellness product has (1) an intended use that relates to 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 where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for such diseases or conditions.
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 relate to weight management, physical fitness, relaxation, mental acuity, and sleep management, among others. For example, a product would fall into this category if it claimed to promote relaxation or stress management without referencing anxiety or sleep disorders.
The second category of general wellness intended uses is comprised of products that promote, track, and/or encourage choices, which, as part of a healthy lifestyle, may help to reduce the risk of and/or may help living well with certain chronic diseases or conditions. FDA’s guidance states that these 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. “Well understood” means that such claims should be generally accepted, e.g., it is generally accepted that a healthy lifestyle is associated with reducing the risk of heart disease.
In addition to satisfying one of the two categories above, the product must also be qualified as “low risk.” Whether a device is low risk for the purpose of CDRH’s guidance is determined by whether the product: 1) is invasive; 2) involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied; 3) raises novel questions of usability; or 4) raises questions of biocompatibility. “Invasive” is defined to mean a product that penetrates or pierces the skin or mucous membranes of the body.
For example, a product intended to mechanically exfoliate the skin to make it smoother and softer is a low risk general wellness product because it relates to a user’s self-esteem and does not penetrate the skin. However, if the product exfoliates the skin in order to enhance the delivery of a topically-applied product containing one or more pharmaceutical ingredients, the product would be considered “invasive” and thus would not be a low risk general wellness product.
Given that the vast majority of health-related apps fall into the FDA’s low risk general wellness category, mobile medical application manufacturers will likely welcome the guidance, as they will not have to bother with the extensive time, labor, and expense that goes hand in hand with product regulation. Indeed, the health tech industry has long been vocal about its aversion to regulation in this space, criticizing the agency for efforts that have been perceived as stifling innovation.
With a projected 500 million people using mobile health apps this year, the regulation (or not) of such apps is an issue with far-reaching impact – it determines whether and how quickly consumers can get their hands on the latest technology. For now, it looks like a win for industry – and for consumers who are eager to take control of their health – but further refinements to the guidance are a given, as release of the draft has only served to kick off the FDA comment period. We resolve to keep you updated on these exciting developments.