FDA Response

Updated: December 17, 2021

Owlet received a Warning Letter from the FDA regarding the Smart Sock’s regulatory status in the United States. The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications. Based on the FDA’s recent letter, Owlet plans to pursue marketing authorization from the FDA for these features.

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 in the U.S. The FDA action is specific to the U.S. only. There has not been a request from the FDA to return or exchange any product at this time. We plan to offer a new sleep monitoring solution in the U.S., which will be available in January 2022. Additionally, we plan to continue to support our current customers and will notify them of any updates to the Smart Sock products that have already been distributed.

After six years on the market, four versions launched and over 1 million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered. We will continue to stay focused on our mission and are cooperating with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies.

Can I continue using my Smart Sock?

The product’s functionality has not changed at this time. We will notify customers of any updates to the Smart Sock products that have already been distributed. Information about the Owlet Care App is available here.

Is Owlet going to obtain FDA marketing authorization to sell the Smart Sock as a medical device?

We plan to work toward the submission of a device application to FDA. We met with the FDA recently to reiterate our commitment to these efforts.

Is the product safe?

The Smart Sock's safety has been validated by third parties, in which it was shown to be safe. In addition, the letter we received from the agency did not identify any safety concern about the Smart Sock.

When will the new sleep monitoring product be available?

In December, we announced the Dream Sock, which will launch in the U.S. in January 2022. Learn more here.

What if I have more questions?

Please contact our Customer Service team (contact@owletcare.com or 844-334-5330 in the U.S.).