Owlet plans to introduce a new sleep monitoring solution instead
Owlet Baby Care has halted sales of its Smart Socks, which monitor children’s sleep patterns, after six years on the market in response to a warning letter it received from federal health officials.
The US Food and Drug Administration (FDA) issued a notice to the company in October saying the product is marketed as a medical device without approval from a federal agency.
The Ovlet Smart Socks are described as being able to track a baby’s heart rate, oxygen level and sleep patterns, which can be read in real-time with the company’s Ovlet app. version of its website Targeted at consumers in another country.
According to the website, the socks are marketed for children up to the age of 5. The product is no longer available on the website for US consumers.
In the warning letter, the FDA said that Owlet violated the federal Food, Drug, and Cosmetic Act by marketing the product “without marketing approval or approval” in the United States.
Under the FD&C Act, “these products are devices because they are intended for use in the diagnosis of disease or other conditions, or for the treatment, mitigation, treatment, or prevention of disease, or to affect the structure or function of any body.” ,” the FDA wrote.
The FDA says it has been notifying the company since 2016 that the Owlette Smart Sock is considered a device under the FD&C Act and “not under a compliance policy for low-risk products that promote a healthy lifestyle.” Comes.”
Owlett previously acknowledged that it had received a letter from the agency saying in an October 4 note that since its inception it has “focused on the well-being of children and the empowerment of parents” and It takes pride in the technology that has reportedly been used with over 1 million children.
At the time, the company also claimed that the product had been evaluated in third-party studies and shown to be safe.
Additionally, the company’s website also states that Ovlet products are not medical devices.
“They are not intended for use as medical devices or to replace medical devices. They are intended to diagnose, treat, treat, alleviate or prevent any disease or health condition, or to examine the anatomy or any physiological process.” Do not intend to replace or modify,” the disclaimer reads.
However, the FDA requested in the warning letter that the company “discontinue any activity resulting in adulteration” of all versions of the product and co-branded products.
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A spokesperson for Owlet told Granthshala Business in a statement that “the agency’s letter did not identify any security concerns regarding the Smart Sock.”
Nevertheless, Owlet confirmed that it would cease sales of the product as a result of the letter and in light of plans to submit a device application to the FDA. Instead, Owlet plans to introduce a new solution for sleep monitoring, which is expected to be available soon.
The company says it plans to “continue to support our existing customers” and will notify customers of “any updates to Smart Sock products it has already delivered.”
The company also reiterated that these actions only affect US customers and no other countries or regions are affected.
“After six years in the market, four versions launched and over one million baby monitoring, we are extremely proud of the innovation and technology that Owlet has delivered,” Owlet said in a statement. “We will continue to focus on our mission and are collaborating with the FDA so that we can continue to provide sleep monitoring products and solutions to parents and children.”