Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million. Both companies market products in a rapidly growing sector of the digital health industry: wearable sensors that track and analyze users’ lifestyles. Jawbone’s UP can track sleep, movement, and diet, interacting with the user’s smart phone to provide data and analysis meant to nudge one toward a healthier lifestyle. BodyMedia’s FIT, recently featured on the popular television show Biggest Loser, tracks exercise, diet, sleep, and various vital signs to help users lose weight and maximize fitness. And a visit to the iTunes store reveals a number of apps in the “Health & Fitness” and “Medical” categories aimed at promoting fitness, good diet, and other aspects of a healthy lifestyle by reading and analyzing data from a peripheral sensor or device.
One of the thornier questions facing companies in this sector is whether and when they must treat their products as FDA-regulated medical devices. BodyMedia, for example, lists its FIT product as class II, 510(k)-exempt “isokinectic testing and evaluation system” under 21 C.F.R. § 890.1925 and additionally lists a class I medical device data system under 21 C.F.R. § 880.6310.
FDA has provided some general guidance on this issue. In its 2011 Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications, FDA stated that it did not intend to regulate apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.” According to FDA, examples included “dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.” This general statement appears consistent with the agency’s historical policies towards lifestyle and exercise products. For example, FDA stated in a 1995 guidance document that it would not regulate “exercise equipment intended only for general physical conditioning” but would regulate equipment “intended to be used for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity.”
Although some types of sensors and other products geared toward fitness and healthy living clearly fall within the unregulated category, difficult questions often arise. For example, may a product provide suggestions for eating modeled after the American Heart Association’s diet and lifestyle recommendations, which are intended to reduce the risk of cardiovascular disease? May a product offer a series of exercises intended to reduce the risk of athletic injuries by strengthening core muscles? What claims can developers make about these products? Additionally, because the statutory definition of a device encompasses products that are intended to affect the structure and function of the body, regulatory questions can arise when a sensor takes measurements by introducing energy into the body.
The rapid growth in this sector may pressure FDA to provide greater clarity about the types of products it intends to regulate, and the types of claims the agency will consider to establish a medical device intended use. Several speakers at FDA’s 2011 public workshop on mobile medical apps focused on this issue, and it likewise showed up in comments filed to the public docket. In the short term, stakeholders should keep an eye out for the finalized mobile medical apps guidance—which FDA has said will be released by the end of the fiscal year—to see if it addresses the issue in greater depth.