On October 1, Owlet received a letter from the U.S. Food and Drug Administration (FDA) regarding the Owlet Smart Sock’s regulatory status. In the letter, the FDA asserts that Owlet’s marketing and functionality in the U.S. renders the Smart Sock a medical device requiring premarket clearance or approval from FDA, and that Owlet has not obtained clearance or approval. It's important to note that the letter does not identify any specific safety concerns; rather, the FDA disagrees about the regulatory status of the product.
We are fully cooperating with the FDA on the regulatory status of the product. We have been engaged with the FDA to ensure our products abide by the agency’s guidance and expectations, and we will continue working closely with the FDA to reach a resolution.
Since our founding, Owlet has been focused on the well-being of babies and empowerment of parents, and we are proud of the technology we’ve created that has been used with over 1 million babies. The Smart Sock has been evaluated in third-party studies, in which it was shown to be safe.
We strongly believe in the significant benefits that sleep monitoring provides to parents of newborns. The feedback from parents and caregivers who use the Smart Sock is overwhelmingly positive.
Wearable technology and digital health are rapidly developing fields with evolving regulatory expectations. We remain committed to working with the FDA – now and in the future – to ensure we can continue to provide our families with cutting-edge technology that supports parents and infants in the home.
How is Owlet responding to the FDA?
We have been actively communicating with the FDA to ensure our products abide by the agency’s guidance and expectations, and we will continue working closely with the FDA to reach a resolution. Please know that we do not believe that this action was taken due to concerns about the product’s safety; rather, the FDA's concern is about the regulatory status of the product.
Is the device safe?
Yes, we are not aware of any major safety concerns, and the Warning Letter does not appear to be predicated on any such concerns. The Smart Sock has been evaluated in third-party studies, in which it was shown to be safe.
Is this a recall?
At this time, there has been no discussion with the FDA regarding the need for a recall.
Will the Smart Sock still notify parents and caretakers?
At this time, there has been no change to the product’s functionality. However, the FDA has asked us to stop marketing the product for these uses. We will communicate with customers on any product updates/changes when we know more.
What modifications will Owlet make?
We will communicate with customers on any product updates/changes when we know more.