{"id":6243,"date":"2021-11-24T15:27:10","date_gmt":"2021-11-24T20:27:10","guid":{"rendered":"https:\/\/dreambabysleep.com\/?p=6243"},"modified":"2022-08-29T17:08:11","modified_gmt":"2022-08-29T17:08:11","slug":"baby-monitor-alternatives-now-that-the-fda-has-pulled-the-owlet","status":"publish","type":"post","link":"https:\/\/dreambabysleep.com\/baby-monitor-alternatives-now-that-the-fda-has-pulled-the-owlet\/","title":{"rendered":"What to Know If You\u2019re Worried About The FDA\u2019s Letter to Owlet"},"content":{"rendered":"

By Carolynne J. Harvey \u2013 Baby Sleep Expert, Author & Founder of Dream Baby Sleep\u00ae<\/span><\/p>\n

If you\u2019re expecting and have an Owlet Sock on your baby registry or you currently own an Owlet Sock you may have heard that the <\/span>U.S. Food & Drug Administration (FDA)<\/span><\/a> issued a warning letter to the company advising them that since the sock is considered a \u201cmedical device\u201d 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: <\/span>what does this mean? Should I stop using mine? What can I get instead? <\/span><\/i>Well, as a baby sleep expert for the last 10 years I\u2019ve been following the baby tech space closely, and I\u2019m here to  simplify the news for you and share some alternatives.<\/span><\/p>\n

The Facts About the FDA Ruling on the Owlet Sock:<\/b><\/p>\n

First, Owlet received a Warning Letter from the FDA on October 5, 2021 regarding the Smart Sock\u2019s regulatory status in the United States\u2014 the FDA objects to the way the Smart Sock is currently being positioned and sold. <\/span><\/p>\n

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.<\/span><\/p>\n

What this means<\/b>: 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.<\/span><\/p>\n

But this isn\u2019t 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. <\/span><\/p>\n

What this means:<\/b>  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.<\/span><\/p>\n

Importantly, The FDA has <\/span>not<\/span><\/i> cited any safety concerns, or asked for a product recall. The FDA\u2019s complaint is about the marketing\/promotion of the device, not the safety or quality of it.<\/span><\/p>\n

What this means:<\/b> Worried parents who have thrown out Rock \u2018n\u2019 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\u2014they should have worded their marketing better.<\/span><\/p>\n

Still, if you were hoping to get an Owlet for your newborn you may be feeling stuck now that you can\u2019t 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:<\/span><\/p>\n

    \n
  1. Smart Monitors<\/span><\/li>\n
  2. Breathing Monitors<\/span><\/li>\n
  3. Traditional Monitors<\/span><\/li>\n<\/ol>\n

    My<\/span> top choice<\/b> is the <\/span>Nanit Smart baby monitor<\/b>. <\/span>
    \n<\/span><\/p>\n