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Owlet’s Plans to Address FDA Letter

10/04/2021

On October 1, Owlet received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding the Owlet Smart Sock. 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. 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 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. Our team is working diligently to respond to the FDA so that we can continue to offer infant sleep monitoring that supports parents.

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. Ninety-four percent of parents reported better sleep, based on a recent survey of 5,000 parents. The product has been recognized as a best baby monitor by What to Expect, Baby Center and The Bump.

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.

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