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Owlet Baby Care has received a warning letter from the Food and Drug Administration regarding their ...
Owlet Baby Care

The FDA Sent A Warning Letter To Owlet Over Its Smart Sock Baby Monitor

The FDA claims Owlet’s marketing of the Smart Sock renders it a medical device, which the company has not received clearance for.

The federal Food and Drug Administration (FDA) has issued a warning letter to Owlet Baby Care over its Smart Sock, a device that uses infrared light to monitor a baby’s heart rate and blood oxygen level. In its letter, the FDA claimed Owlet’s marketing of the Smart Sock rendered the product a medical device that would traditionally need premarket FDA clearance or approval, which Owlet does not have. The FDA has requested Owlet cease commercial distribution of the Smart Sock as a product intended for measuring blood oxygen saturation and pulse rate.

Owlet said it received an official warning letter from the FDA on Oct. 1 in an SEC filing submitted earlier this month. “The Warning Letter asserts that the Company’s marketing of its Owlet Smart Sock product (the ‘Smart Sock’) in the United States renders the Smart Sock a medical device requiring premarket clearance or approval from FDA, and that the Company has not obtained such clearance or approval in violation of the Federal, Food, Drug, and Cosmetic Act,” the filing said.

Owlet’s Smart Sock, which is currently priced at $299, is marketed as an award-winning product that tracks “the most important indicators of your baby’s well-being” while they rest. It tracks heart rate, oxygen levels, and sleep trends and pairs with a smartphone app to alert caregivers or parents when a baby’s readings fall outside of preset zones.

Owlet Baby Care

In its letter to Owlet, the FDA requested the company stop commercial distribution of the Smart Sock for use in measuring blood oxygen saturation and pulse rate for the intended purpose of identifying or diagnosing desaturation and bradycardia via an alarm or notification function. The FDA also alerted Owlet to marketing claims made by the company, which the FDA argued rendered the Smart Sock a medical device.

In its SEC filing, Owlet said it intended to cooperate fully with the FDA and would pursue a marketing authorization application for uses of the Smart Sock identified as being medical device uses but could not guarantee the FDA would be satisfied with its actions. Romper has reached out to Owlet for additional comment.

Despite Owlet’s willingness to work with the FDA on a solution, news of the federal agency’s warning caused Owlet Inc. stock to drop nearly 24% earlier this week. According to CNN’s Market Watch, Owlet only recently began trading shares in July following a merger with special-purpose acquisition company (SPAC) Sandbridge Acquisition Capital.

Owlet has placed a disclaimer on its website, which emphasized no Owlet product was a medical device nor intended to be used to “diagnose, cure, treat, alleviate, or prevent” any type of disease or health condition. “The Smart Sock is only intended to assist you in tracking your child’s well-being and is not intended to replace you as a caregiver,” the disclaimer read. “You are responsible for the health and well-being of your child and following safe sleep, health, and care guidelines.”