In yet another instance of the federal government’s war on parents, the Food and Drug Administration is cracking down on a popular baby monitoring device called the Owlet Smart Sock. While the agency’s concerns have nothing to do with the product’s safety, Owlet Baby Care has been forced to pull its device off the market.
The Owlet Smart Sock is a high-tech baby monitoring device that allows parents to track their baby’s sleep patterns, heart rate, and oxygen levels. Through a washable “sock” that easily wraps around the baby’s foot and connects to a wireless base, it alerts parents should their baby’s heart rate or oxygen levels get too high or too low. Parents can also monitor oxygen levels and sleep trends through Owlet’s free iOS and Android app.
That is, parents could do these things, prior to the FDA using its regulatory powers to ban parents from being able to purchase the high-tech baby monitoring device. In a warning letter dated Oct. 5, the FDA alleged Owlet was marketing its Smart Sock in violation of the Federal Food, Drug, and Cosmetic Act.
The agency claims the sock is a medical device that requires premarket approval to sell in the United States because it is “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.” Until Owlet obtains proper approval, the FDA ordered the company to stop selling the product or face “seizure, injunction, and civil money penalties.” (Read more from “The FDA Forces a Popular Baby Monitor off the Market — But Not Because It’s Unsafe” HERE)
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