FDA Response

Updated: November 21, 2022

Owlet received a Warning Letter from the FDA in October 2021 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 asserted that the Smart Sock should be classified as a medical device in the U.S. because of the live heart rate and oxygen notifications. Currently, Owlet is in the process of pursuing marketing authorization from the FDA for these features.

We are no longer selling the Smart Sock in the U.S. There has not been a request from the FDA to have owners of Smart Sock in the market return or exchange any product at this time. Since January 2022, Owlet has offered a new baby monitoring solution in the U.S., called Dream Sock, which addressed the claim in FDA’s letter. However, we plan to continue to support our current customers, as needed, for the Smart Sock products that have already been distributed.

After seven years on the market, five versions launched and over 1.5 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 the best monitoring products and solutions to parents and babies. We plan to file a submission to the FDA by the end of 2022 for the opportunistic live heart rate and oxygen display and notifications around low/high heart rate and low oxygen to be incorporated into Dream Sock.

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?

In December, 2022 we announced our FDA Software-as-a-medical device submission for heart rate and oxygen displays and notifications. The FDA accepted our de novo submission for substantive review. Designed for parents and caregivers to monitor healthy babies at home, the Health Notifications software would provide displays of live heart rate and oxygen saturation for babies and opportunistic notifications when these readings move beyond certain ranges. In October of 2022, we also announced the submission of a 510(k) pre-market notification for a prescription-only monitor designed for use in-home for babies under the supervision of a physician. Read our announcement, here.

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.

How is the Dream Sock different from the Smart Sock?

The award-winning Dream Sock is designed to help parents ensure that Baby develops healthy sleep habits early on and gets a good night’s sleep. While the Smart Sock had features notifying users based on changes to heart rate and oxygen levels outside of preset values, the Dream Sock tracks Sleep Quality Indicators to help caregivers understand their baby’s sleep and be prompted when their little one may be uncomfortable or need assistance falling back to sleep. Sleep Quality Indicators tracked by the Dream Sock include wakings, movement, heart rate and average oxygen level, which we believe can provide an indication of sleep quality and help parents with better sleep insights for their baby. Additionally, based on your baby’s age, when they last slept and how long their last sleep session is (all tracked through the Dream Sock), our Predictive Sleep Technology will inform you of Baby’s next sleep window in the Dream App.

What if I have more questions?

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