(RxWiki News) A company has pulled a product that monitors babies' vital signs from the market after a warning letter from the US Food and Drug Administration (FDA).
The Smart Sock is no longer available for sale in stores after Owlet, the company that manufactures the product, pulled it from the market.
The removal of the Smart Sock from store shelves followed a warning letter from the FDA. In the letter, the FDA said the Smart Sock had been brought to market without proper approval as a medical device.
According to the agency, that action was a violation of the Federal Food, Drug, and Cosmetic Act, which mandates that all medical devices undergo a strict FDA approval process before they can be sold.
Owlet has claimed on its website that the Smart Sock is not a medical device. However, the FDA said in the warning letter that "... these products are devices because they are 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."
The Smart Sock was designed to track vital signs like pulse rate and blood oxygen concentration in children ages 0 to 5. The product also tracks sleep patterns.
According to the FDA, the agency had been discussing this issue with Owlet since 2016. The agency did not openly identify any safety issues with the Smart Sock. The issue at hand appears to focus solely on whether the product requires FDA approval.
Since pulling its product from the market, Owlet has announced its plans to replace the Smart Sock with a new baby health tracking device.
Although Owlet pulled the Smart Sock from the market, various retailers may still sell the product online. Talk to your baby's doctor before using any new health-related device — especially if that device is not FDA-approved.