Owlet had decided to cease selling its baby monitoring smart sock gadgets due to a new FDA warning, mainly because it began selling them before the FDA approved them.
The FDA did not order a recall, but the business has voluntarily ceased sales to comply with the regulatory body. Still, it will continue to support any devices already purchased.
According to the Independent Women's Forum, the Owlet Smart Sock is a high-tech baby monitor that lets parents monitor their child's sleep habits, heart rate, and oxygen levels.
WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration outside the headquarters on July 20, 2020, in White Oak, Maryland.
The smart baby monitoring sock warns parents if their baby's heart rate or oxygen levels are too high or too low using a washable "sock" that conveniently wraps around the baby's foot and connects to a wireless base. Owlet's free iOS and Android app also allow parents to track oxygen levels and sleep patterns.
FDA Flags Owlet for Selling Baby Monitoring Sock Gadget Without Approval
Owlet has been around for a long time and is widely regarded as one of the finest Newborn applications or wearables for assisting parents. However, it is withdrawing its wearable baby monitoring sock from the market after receiving a warning from the FDA about its sale without the necessary permission.
The monitoring firm is not aggressive or at odds with the FDA, and it is following the health agency's recommendation for its products to be placed on the market. Owlet will continue to seek regulatory approval and bring its products to market in the future, particularly those that assist in monitoring children.
It is crucial to highlight that existing Owlet sock users will continue to receive support for their applications and devices.
US FDA flagged Owlet in an update in October for selling monitoring equipment without the agency's permission for distribution and public use. Nonetheless, the FDA has raised concerns about the device's emphasis as a detecting technology that can view personal information about newborns, which requires their clearance.
Owlet Underscored That Baby Sock Monitor is Safe
Owlet highlighted in its statement that the agency "did not uncover any safety concerns regarding the Smart Sock" and that it intends to seek FDA marketing approval. However, experts (per Science Direct) predict that this will be a lengthy and challenging procedure that will take several years.
Third parties have well-documented and certified the safety profile of the Owlet Smart Sock. Raymond March, director of FDAReview.org at the Independent Institute and a faculty fellow at North Dakota State University's Center for the Study of Public Choice and Private Enterprise, summed it up nicely.
Apart from an audio or video monitor, parents had few alternatives for monitoring their newborns as they slept before the Owlet Smart Sock despite millions of babies surviving without its help.
The Smart Sock was not purchased as a "medical device" to diagnose, cure, or prevent disease in their babies by the parents who used it to watch their newborns. In a May 2020 review of the product, the Journal of Clinical Sleep Medicine observed that the corporation specifically said that it wasn't selling itself as such.
Almost 1 million parents purchased the Owlet Smart Sock for one simple reason: to reassure them that their infants were still breathing and alive.
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