Although consumers are warming up to the idea of putting on a smartwatch or a fitness-focused wearable to help them live a healthier lifestyle, Apple and the other tech companies building wearables are faced with a variety of rules and regulations — most notably those of theU.S. Food and Drug Administration (FDA), which has decided that it won’t regulate most wearable devices, and will instead only monitor those that aim to diagnose and treat serious diseases.
Draft guidance from the agency draws a line between the devices that it will and won’t regulate. Most wearable devices sold today, which promote “general wellness” in the form of a healthy lifestyle, won’t need to be regulated. (As Popular Science notes, this doesn’t mean that the FDA has approved these devices; it just means that it won’t regulate them.)
On the other hand, devices that make specific claims about diagnosing or treating a disease or condition will be subject to regulation by the FDA. Risk is also a key factor for the FDA, and wearables generally carry a low level of health risk. Devices that would require ingestion, injection, or any other invasive procedure would require FDA oversight.
Low risk, general wellness devices won’t need FDA approval
The FDA has issued preliminary guidance defining its criteria for determining when wearable devices like the forthcoming Apple Watch should be classified as regulated medical devices. The draft guidance on the agency’s “Policy for Low Risk Devices” (PDF), which is open for comment for 90 days, clarifies the FDA’s compliance policy for “low risk products that promote a healthy lifestyle.” The guidance defines the category of general wellness products as those that are intended solely for general wellness use and present a very low risk to users’ safety.
General wellness products either have “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity” or “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.” The first category could include products that help users with weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function. The document notes that the category does not include products that claim, for example, to diagnose or treat obesity, to treat an eating disorder, or to treat anxiety. Devices that do make claims about the treatment or diagnosis of diseases and conditions will be subject to further scrutiny by the FDA.
The second category of general wellness products — which aim to help reduce the risk or impact of a disease or condition — includes products that promote, track, or encourage choices that may help reduce the risk of certain disease or conditions, or may help users to live well with a certain disease or condition.
Devices can make health claims when lifestyle choices are known to reduce the risk of disease
The FDA’s preliminary guidance notes that “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,” indicating that devices that track activity or biological data like the user’s pulse can make claims related to a disease when it’s understood that lifestyle choices can reduce the risk of the disease or aid its management.
Whether a device is low-risk is determined by whether or not the product is invasive, involves a technology that could pose a risk to the user’s safety, raises “novel questions” or usability, or raises questions of biocompatibility. Some of the FDA’s examples of low-risk general wellness products include a mobile app that plays music to relax the user and help him or her manage stress; an app that monitors and records daily energy expenditure and cardiovascular workout activities; or an app that 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.”
In another example, the document notes that “A portable product that claims to monitor the pulse rate of users during exercise and hiking” both avoids referring to a disease or medical condition and poses a low risk to the user’s safety, and therefore qualifies as a low-risk general wellness product.
Few wearable devices currently on the market should be subject to FDA oversight
As Apple Insider points out, few of the wearable devices currently on the market appear to be on the wrong side of any of the rules laid out in the FDA’s guidance. For its part, Apple is known to have repeatedly met with the FDA before its unveiling of the Apple Watch, most likely to ensure that the wearable and its focus on health tracking would meet any forthcoming regulatory requirements. Following the release of iOS 8 and the Health app, the agency said of the meetings that Apple “wants to make sure they are on the side of the FDA,” and that “the earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated.”
At the same time, reports have shown that Apple is in investing an increasing amount of money in lobbying in Washington. Lobbyists work to help their clients increase their influence in the decision-making process in Washington, particularly as it relates to legislation and regulation policy. 9to5Mac notes that Apple will likely continue working with the FDA — and will also continue to invest in lobbying over issues such as strong device encryption or patent litigation.
The news about the FDA’s draft guidance is generally good news for tech companies interested in developing wearable devices, as it means that many will encounter one less regulatory hurdle on the path to bringing their product to market. For consumers, it means that they’ll need to exercise the same judgment that they would in any other area that isn’t regulated by the FDA, such as when choosing vitamins or supplements.
However, as the area of wearable devices matures, the FDA will continue to examine the risks and benefits that devices can offer to consumers. And while it seems that few wearables will need FDA oversight now, that may simply be due to the early nature of the applications that have been developed for these new technologies. As more applications of a medical — instead of general wellness — nature emerge, more devices are likely to fall under FDA regulation. It seems likely that a future version of the Apple Watch, for example, could be subject to new regulations that don’t yet exist in order to ensure the safety of consumers who use health and medical applications that have yet to be developed.