Owlet FDA Response
Updated: December 1, 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 and no other countries or regions are affected by this. There has not been a request from the FDA to return or exchange any product at this time...
