FDA Response

Updated: February 1, 2022

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 are no longer 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 now offer a new sleep monitoring solution in the U.S., which we launched in January. 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. Additionally, existing Smart Sock owners have the ability to update their product’s functionality to the functionality of a Dream Sock, which can be done through the Dream App. The Dream App is available for both iOS and Android phones.

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 in third party evaluations, 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?

The Dream Sock and Dream Duo are now available in the U.S. 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.).