In 2018, Apple made headlines when it released a new version of its smartwatch that included an FDA-cleared electrocardiogram feature. Conor Hale, New Apple Watch receives FDA clearance for built-in ECG, Fierce Biotech (Sept. 12, 2018). This feature cemented the smartwatch’s classification as a medical device. With the popularity of wearable health devices, from fitness trackers to smartwatches, on the rise among adults, it was only a matter of time before much younger demographics were targeted—babies and children.

Smart baby monitors tout features to help ease the anxieties that accompany new parenthood. For example, Owlet, Inc. advertises that its wearable, smart baby monitor is “up all night for your peace of mind.” Owlet® Dream Sock, Owlet, (last visited May 18, 2022). As these monitoring systems become more sophisticated, companies will not only have to contemplate intellectual property protection, but they may also have to consider whether their product qualifies as a medical device requiring premarket approval or marketing clearance from FDA.

According to FDA, “[a] baby product is considered a medical device if claims to cure, treat, prevent, or reduce a disease or condition are made in the product’s labeling, packaging, or advertising.” Baby Products with SIDS Prevention Claims, FDA (May 18, 2022)see also 21 U.S.C. § 321(h). Last year, Owlet pulled its wearable baby monitor, the Smart Sock, off the market after FDA informed the company in a warning letter that the monitor had been brought to market without the required regulatory approval. The Smart Sock wraps around a baby’s foot to track sleep patterns, blood oxygen saturation, and heart rate. This information is transmitted to a connected base station and smartphone app to alert caregivers to potential health conditions. FDA noted that the product’s monitoring of these vital signs is intended to diagnose desaturation and bradycardia to alert users that the measurements are outside preset values. This put the Smart Sock within the definition of a medical device, thus requiring marketing authorization from FDA. Warning Letter to Owlet, Inc. (Oct. 5, 2021). Earlier this year, Owlet launched its new smart baby monitor that still tracks the baby’s heart rate but only sends alerts related to sleep quality issues. According to its website, Owlet plans to seek authorization to market the heart rate and oxygen notification features that sparked the warning letter. FDA Response, Owlet (updated Feb. 1, 2022).

INVU, a separate wearable device made by Nuvo Group, has already received market clearance from FDA. This device is a wearable band that measures and displays maternal heart rate, fetal heart rate, and uterine activity in a pregnant woman in the third trimester. The device is indicated for use both at healthcare facilities and at home to allow for remote monitoring. Ltr. from FDA to Nuvo Group Ltd. (May 28, 2021). With digital health on the rise, industries like the baby monitoring industry may see an uptick in applications to FDA for marketing approval.