The U.S. Food and Drug Administration (FDA) has ordered Owlet, the popular smart sock baby monitor, to stop selling its product unless it receives proper approval from the regulating agency.
In a letter sent to the Utah-based company, the FDA stated that the Owlet Smart Socks had been touted as a medical device, and yet it did not seek the proper clearance to market the product for such a purpose.
Owlet is popular with many parents because the lightweight gadget could monitor the baby's heart rate, oxygen level, hours of sleep, and sleep patterns. Because of these features, the FDA said that the company should have filed for medical device approval.
How Owlet Works
Owlet launched its third-generation smart sock baby monitor early this year with a special feature that could give parents some peace of mind. The device alerts moms or dads for any concerning changes about their baby's vitals. The gadget has also improved its capacity to monitor the vitals of kids below five years old or if they are less than 55 pounds in weight, which means that the baby could grow with the device.
The sock is featured with pulse oximetry and other electronics that can sync to the parents' smartphones. It also has a base station that includes various light notifications so parents can easily check their baby's vitals if the sock is wrapped around their foot.
In response to the FDA warning, Owlet agreed to stop selling the Owlet Smart Socks in the U.S. only while it pursues the needed marketing authorization. The company also said that it would be offering a new sleep device to support its millions of current users but emphasized that the functionality of the product has not been altered. They will be informing customers of any changes in due time.
Despite this, Owlet has maintained that its smart socks are low-risk and created to promote a healthy lifestyle for families. The company has assured its users that their device is still safe to use.
Parents Petition Support for Owlet
Amid the FDA warning, parents have opened a petition on Change.Org to ask the FDA to retract its order since many families will benefit from the product. The petition has received nearly 85,000 signatures as of press time.
"There are other products and substances on the market the FDA could be targeting," the petitioner wrote. "The baby monitor's sole job is to provide peace of mind and help us keep an eye on our little ones."
One supporter said that the FDA has been unfair to Owlet from the beginning, while another noted that the FDA should understand that this device is helping the mental anxieties of parents.
Meanwhile, Owlet also has a baby camera, a baby monitor with HD video, a pregnancy band, and the Dream Lab sleep guide, which have not been affected by the FDA order. The company is also developing an update to its pregnancy band that could also monitor the vitals of the unborn child.
