If you are the parent of a newborn or infant in 2021, you most likely know about all the innovative new tech gadgets coming to market for child monitoring. One of the most popular new products on the market currently is the Owlet Smart Sock. The smart sock is intended to monitor blood oxygen levels as well as heart rate and alert parents if these measurements go out of range.
According to the FDA, the company has been marketing their Owlet Smart Sock product without premarket approval, which is a violation of the Food, Drug, and Cosmetic Act. Because their product is considered an unapproved medical device and misbranded, the FDA is requiring that Owlet cease commercial distribution of the device effective immediately.
The company has responded with a statement that effectively states they will look at FDA clearance options and that they will discontinue sales. When a product is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, the FDA considers it a medical device. Products that measure blood oxygen saturation and pulse rate are devices when they are intended to identify (diagnose) desaturation and bradycardia and provide an alarm to notify users that measurements are outside preset values.
The company has stated that their products are validated by third parties, but that is not enough to demonstrate FDA clearance to market and sell the product in the United States. Owlet will need to obtain the full FDA clearance prior to continuing sales of the product and it seems that they intend to do so.
To read the FDA warning letter, please click on the link below:
To read Owlet's response, click the link below: https://owletcare.com/pages/fda-response