Owlet has stopped selling its line of smart baby monitoring socks, which are supposed to track a baby’s vital signs and sleep patterns, after receiving a warning letter from the Food and Drug Administration (FDA). First reported by News from Déseret, the FDA letter states that Owlet’s Smart Socks are considered medical devices because they provide heart rate and oxygen level notifications, and that the company has sold them without “marketing authorization, clearance or clearance ”from the FDA.
Owlet has since removed his family of smart socks, as well as any outfits that include the device, from his site. “The Owlet Sock product family is currently unavailable,” reads the Smart Socks product page. “Check back in the coming weeks to see the latest addition to the nest. The Owlet smart socks still seem to be available in other online marketplaces, like Bed Bath & Beyond, Amazon, and BuyBuyBaby – for now at least. The Owlet smart socks will still be available for purchase outside of the United States.
The FDA explains that Smart Socks are medical devices, in particular because they measure blood oxygen saturation and heart rate in order to “identify (diagnose) desaturation and bradycardia and provide an alarm for inform users that the measurements are outside the predefined values. As mentioned in the letter, Owlet previously claimed that its Smart Socks are low risk products, not medical devices. The FDA apparently informed the brand that this had not been the case since 2016.
Owlet posted a response to the FDA on its site, noting that it plans to comply with the FDA’s request and would seek marketing approval for its functionality to track heart rate and blood oxygen levels. . The company also says the FDA has “not identified any safety issues with the Smart Sock” and reassures existing sock owners that “there have been no changes” in its functionality.
Owlet also alludes to the introduction of a similar new product in his letter, stating that he plans to offer “a new sleep monitoring solution”, which will be available “soon”. The edge contacted Owlet about their upcoming product and whether it would replace the Smart Sock, but did not receive an immediate response.
Smart baby monitors, like Owlet’s Smart Socks, have been criticized in the past. Doctors have suggested that they may in fact put infants at risk, as they are not classified as medical devices and are not subject to certain regulations and surveillance.
“The security of the Smart Sock has been validated by third parties, in which it has been shown to be safe,” Owlet says in his article. “In addition, the letter we received from the agency [the FDA] has not identified any safety issues with the Smart Sock.