What to Know If You’re Worried About The FDA’s Letter to Owlet

By Carolynne J. Harvey – Baby Sleep Expert, Author & Founder of Dream Baby Sleep®

If you’re expecting and have an Owlet Sock on your baby registry or you currently own an Owlet Sock you may have heard that the U.S. Food & Drug Administration (FDA) issued a warning letter to the company advising them that since the sock is considered a “medical device” and medical devices require FDA approval (which the sock does not currently have), the Owlet Sock should be pulled from the market.   And you may be wondering: what does this mean? Should I stop using mine? What can I get instead? Well, as a baby sleep expert for the last 10 years I’ve been following the baby tech space closely, and I’m here to  simplify the news for you and share some alternatives.

The Facts About the FDA Ruling on the Owlet Sock:

First, Owlet received a Warning Letter from the FDA on October 5, 2021 regarding the Smart Sock’s regulatory status in the United States— the FDA objects to the way the Smart Sock is currently being positioned and sold. 

One notable outcome from this letter is that as of November 21, 2021, parents can no longer download the Owlet app on the Apple app store. The app is currently still available for Android.

What this means: Any customers setting up a new Owlet Smart Sock can no longer download their app from the app store, even if they purchased the product before the FDA action.

But this isn’t the first time the FDA has expressed concerns about the Owlet Smart Sock. Since 2016, the FDA has been telling Owlet that the Smart Sock meets the definition of a medical device under the FD&C Act, rather than  falling under the compliance policy for low-risk products that promote a healthy lifestyle. 

What this means:  The FDA thinks the Owlet sock is a “medical device” by the FDA, and in their opinion, should not be sold as a consumer product.

Importantly, The FDA has not cited any safety concerns, or asked for a product recall. The FDA’s complaint is about the marketing/promotion of the device, not the safety or quality of it.

What this means: Worried parents who have thrown out Rock ‘n’ Plays and Boppy Loungers can relax: the safety of the Owlet Sock is NOT in question.  In my humble view, this was more a poor business decision and marketing misstep by Owlet—they should have worded their marketing better.

Still, if you were hoping to get an Owlet for your newborn you may be feeling stuck now that you can’t download the Smart Sock app and the future of the product is in question. The good news is as a parent there are still several great baby monitor options. These fall into three categories:

  1. Smart Monitors
  2. Breathing Monitors
  3. Traditional Monitors

My top choice is the Nanit Smart baby monitor

  • The Nanit Pro gives you epic camera clarity and enables you to track baby’s sleep, breathing and growth.  
  • My entire team of sleep coaches at Dream Baby Sleep love it when our clients have the Nanit camera, because it provides real intelligence that we can use to make informed recommendations based on the facts (rather than guessing how the night went).
  • One of the coolest features unique to the Nanit Pro is its Breathing Wear. Sold separately as pajamas, swaddle, sleep sack or a simple band of fabric to wrap around the baby’s torso that monitors the baby’s heart rate. This provides very similar info as the Owlet did.
  • The camera uses an ingenious sensor-free method that instead measures the movement of the fabric’s geometric print down to the pixel. (If you want one, take advantage of Nanit’s Black Friday sale with 25% off sitewide!)


My second choice is the Motorola Hubble. My team and I love Motorola monitors. Before Nanit was available I used it personally.

  • The Motoroal Hubble allows you to check on your baby from anywhere because it’s wifi-enabled.
  • The infrared night vision will allow you to keep watch on your sleeping baby and offer  remote operation.
  • The portable camera makes it easy for you to move it from room to room without wires due to the built-in battery.

There are tons of other monitors to choose from, but if you’re looking for an Owlet Smart Sock alternative the only player in the game worth considering (in my opinion) is Nanit. 

If you’re exhausted and looking for other ways to help your baby sleep better, stay tuned for Dream Baby Sleep’s – Sleep Lab small business Saturday deal.  It’s our deepest discount of the year and only happens once a year!

Keep in mind that Dream Baby Sleep may receive commissions when you click our links and make purchases. However, this does not impact our reviews and comparisons. We try our best to keep things fair and balanced, in order to help you make the best choice for you.

About Dream Baby Sleep

Dream Baby Sleep® is a loving group of certified experts who are successfully teaching families how to create and maintain healthy sleep. By studying the temperament of your baby, parenting style and family dynamic we’re able to draw from all sleep training methods available to improve sleep.  If you have additional sleep questions feel free to schedule a free 15-minute sleep consultation by visiting www.dreambabysleep.com/scheduler.


Instagram: @dreambabysleep

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