The FDA Forces A Popular Baby Monitor Off The Market — But Not Because It’s Unsafe

The FDA Forces A Popular Baby Monitor Off The Market — But Not Because It’s Unsafe

The Food and Drug Administration alleges Owlet's Smart Sock is a medical device that requires premarket approval to sell in the United States. The process may take years.
Kelsey Bolar
By

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.”

The Smart Sock Is Safe

In its response, Owlet stressed the agency “did not identify any safety concerns about the Smart Sock” and said it plans to pursue marketing authorization from the FDA. But experts say that will be a long, arduous process that will take several years.

Owlet Smart Sock’s safety profile has been well-documented and validated by third parties. Raymond March, director of FDAReview.org at the Independent Institute and a faculty fellow at the Center for the Study of Public Choice and Private Enterprise at North Dakota State University, summed it up well:

The Smart Sock isn’t perfect. A study published in the Journal of the American Medical Association found it was 90 percent accurate in detecting low oxygen levels and a low pulse. This is not ideal. As study leader and physician Chris Bonafide noted, ‘If something is going wrong with a sick infant, you would want to know that 100 percent of the time.’

But the choice parents face is not between picking perfect or imperfect monitoring devices. The FDA has never approved a completely effective product because no such product exists.

Prior to the Owlet Smart Sock, parents had few options to monitor their babies while they sleep, aside from an audio or video monitor. While millions of babies have survived without the help of a Smart Sock, the product is a natural progression in an increasingly tech-savvy and digital world.

The parents who have used the Smart Sock to monitor their newborns did not purchase it as a “medical device” to diagnose, treat, or prevent disease in their babies. As the Journal of Clinical Sleep Medicine noted in a May 2020 review of the product, the company explicitly made clear it wasn’t marketing itself as such.

Indeed, more than 1 million parents purchased the Owlet Smart Sock and it was for a simple reason: to assure them that their babies were still breathing and alive.

A NICU Off-Ramp

In 2019 when I got pregnant with my first child, I heard about the Owlet Smart Sock but resisted purchasing it. I read that for some parents, the extra monitoring could cause more anxiety by encouraging them to obsessively check levels. I also read about the potential for false alarms causing unnecessary scares, and noted that at $300, it’s a pricey device.

But when my water unexpectedly broke at 30 weeks, eventually resulting in a premature birth, purchasing the Owlet Smart Sock for our daughter was a no-brainer. After more than a month in the Newborn Intensive Care Unit (NICU), doctors told me my daughter was finally ready to go home. While you’d think I’d be elated by the news, the prospect of leaving the nurses, doctors, monitors, and 24/7 care gave me severe anxiety.

At that point, the NICU was all I knew. I had become reliant on monitors tracking my baby’s heart rate and oxygen levels, which notified us of any problems. Leaving them made me feel vulnerable again. To go home, I needed training wheels.

When I asked for their thoughts about the Owlet Smart Sock, doctors assured me they wouldn’t discharge my baby without every confidence that I wouldn’t need such a device. If I purchased it, the Smart Sock would be for me, not the baby, they stressed. But unlike the FDA, they also told me that as a parent, purchasing the Smart Sock was my choice.

The Owlet Smart Sock was easy to use, reliable, and something I’ve since recommended to countless friends. Today as I await the birth of my second child, I feel a great deal of comfort knowing that I can use it again.

Current customers can still use their Smart Socks and so long as it’s already downloaded, we still can use the app. But other anxious, struggling new parents no longer have the option to monitor their babies using this device. In addition to pulling the product off the market, the Owlet Care App was removed from the app store for iOS devices.

Will the Owlet Smart Sock Come Back?

The company said it will “share more soon” about its plans to pursue marketing authorization from the FDA. But “soon” isn’t soon enough for the thousands of parents and newborns whom the Owlet Smart Sock could help now. It’s not soon enough for the one in seven mothers who suffer from some form of postpartum anxiety or depression. It’s not soon enough for the 2,300 babies in the United States who die of Sudden Infant Death Syndrome each year.

Banning a safe, tech-savvy monitoring device from the free market does nothing to further the well-being of babies or anxious parents. Doing so under the guise of protecting customers, with the FDA’s outdated marketing regulations, is cruel.

Like all baby products, Owlet made clear what any good parent already knows: We are responsible for our baby’s health and well-being, and it’s up to us to follow safe sleep guidelines. The Owlet Smart Sock was a welcome addition to parents’ arsenal to assist in that effort, and we should be wary that federal bureaucrats so easily just took it away.

Kelsey Bolar is a contributor to The Federalist and a senior policy analyst at Independent Women's Forum. She is also the Thursday editor of BRIGHT, a weekly newsletter for women, and the 2017 Tony Blankley Chair at The Steamboat Institute. She lives in Washington, DC, with her husband, daughter, and Australian Shepherd, Utah.

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