FDA WARNING_LETTER - Owlet Baby Care, Inc. - July 26, 2021

The FDA issued a Warning Letter to Owlet Baby Care, Inc. on October 5, 2021, regarding the marketing of their Owlet Smart Sock Family products (versions 1, 2, 3, Smart Sock Plus, and co-packaged products like Owlet Monitor Duo). The FDA determined these products are devices under section 201(h) of the Act, intended for diagnosing conditions like desaturation and bradycardia by measuring blood oxygen saturation and pulse rate and providing alarms.

The core violation is that Owlet Smart Socks are being marketed in the United States without marketing clearance or approval, making them adulterated under section 501(f)(1)(B) of the Act. This means the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). The FDA cited marketing examples from July 2021, such as "Track the most important indicators of your baby’s health–like oxygen level, heart rate," and "If your baby’s readings leave preset “safe” zones, the Smart Sock will immediately notify you."

The FDA has corresponded with Owlet since 2016, stating the Smart Sock meets the definition of a device and does not fall under the General Wellness guidance for low-risk products. Owlet is requested to cease commercial distribution of the device for the discussed uses. Failure to address these violations promptly may result in regulatory actions including seizure,