FDA Tells Owlet to Stop Selling Its Smart Sock Baby Monitor

Owlet has been forced to stop selling its popular Smart Sock for monitoring baby heart rate, oxygen levels, and sleep trends.

As DeseretNews reports, the US Food & Drug Administration (FDA) sent Owlet a warning letter last month stating that the company was “marketing Owlet Smart Socks in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).”

The reason for the violation is because the Smart Sock is classed as a medical device due to the fact they “are 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 requested Owlet stop selling the device in the US, and Owlet has now complied with that request. In an FDA Response post Owlet said:

“As a result of the letter and in light of our plans to submit a device application to the FDA, we will no longer be selling the Smart Sock. We plan to offer a new sleep monitoring solution, which we believe will be available soon. We also plan to continue to support our current customers. There has not been any change to your product’s functionality or a request from the FDA to exchange or return your product at this time. We will notify customers of any updates to the Smart Sock products that have already been distributed. This action is specific to the U.S. only and no other countries or regions are affected by this.”

Owlet also pointed out that the letter “did not identify any safety concerns about the Smart Sock,” which will be welcome news to over a million parents who have purchased one.

It's safe to continue using the Smart Sock, but in the US they are no longer available for sale. Parents will be left waiting for the new sleep monitoring solution Owlet is working on, but also for the FDA to approve it being marketed and sold.