FDA Grants De Novo Authorization to SNOO Smart Sleeper

SNOO parents are used to amazing innovations. After all, there is no other pediatrician-designed baby bed that’s trifecta of womb-like sensations—snug swaddling, gentle motion, and calming white noise—adds 1 to 2 hours to a baby’s sleep. But that was just the beginning for Happiest Baby’s SNOO Smart Sleeper!

We are proud to announce that SNOO is the first—and only—medical device to receive De Novo authorization from the Food and Drug Administration (FDA) for its ability to keep sleeping babies safely on their backs. (For important safety information visit www.happiestbaby.com/fda.)

Back-sleeping is the number one safe-sleep recommendation by all public health authorities in the United States, including the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). In fact, placing babies to sleep on the back is “the single most effective action that parents and caregivers can take to lower a baby’s risk of SIDS,” according to the National Institutes of Health.

Why Back-Sleeping Is So Important

Back-sleeping is proven to significantly reduce infant sleep death, an unspeakable tragedy that claims the lives of about 3,500 infants in America each year. Sadly, almost two-thirds of infant sleep deaths occur when babies roll to—or are placed on—the side or stomach. And, compared with back-sleeping, babies who sleep on their tummies have a three to four times higher risk of death. (And that can go up to 13-fold increased risk of SIDS for babies who roll over when swaddled or with soft toys or bedding in their bassinet or crib.)

Experts think sleeping on the belly position may lead to SIDS by causing the baby’s mouth and nose to get blocked by soft bedding. Having the face so close to the mattress may also cause little ones to “rebreathe” their own exhaled breath, leading to a rise in carbon dioxide and a drop in oxygen in the body. It seems that being on the belly may reduce a baby’s drive to breathe and can lead to them “forgetting” to breathe. Some babies may also have a problem with the part of their brain that activates this wake-and-breathe signal. (Learn more about stomach sleeping.)

During the late 1980s, doctors began to recognize that stomach sleeping was a key trigger of infant sleep death, and in 1994, the AAP launched a national Back to Sleep parent education campaign to reduce these deaths. At first, the initiative was highly successful. By 2000, sleep fatalities dropped from about 5,500 to roughly 3,500 per year. However, since 2000, SUID deaths have remained stubbornly stuck at about 3,500 a year. And in June 2022, the AAP acknowledged our nation’s lack of progress in reducing these tragedies and reiterated their strong recommendation that the safest sleep position for infants under 12 months was on the back.

How SNOO Keeps Babies Safely on the Back

SNOO helps protect babies by keeping them secured on the back as they sleep. This is all thanks to our thoughtfully designed SNOO Sack swaddles. The sack has patented looped “wings” that slide onto SNOO’s built-in safety clips to keep the baby from rolling to the stomach during sleep. (SNOO is designed to prevent turning on unless these safety clips are properly engaged.) Once a baby is successfully swaddled in their SNOO Sack and clipped into their SNOO Smart Sleeper, they remain secured on the back all night or nap long.

The Future of Safe Infant Sleep

This groundbreaking FDA De Novo authorization comes at a critical time in infant sleep safety. While the Safe Sleep for Babies Act officially banned the manufacture and sale of dangerous crib bumpers and inclined infant sleep products in 2022, babies continue to die in their sleep. In January 2023 we learned that at least a dozen infants died while sleeping in Fisher-Price and Kids2 inclined sleepers—years after the products were recalled. Perhaps even more disheartening, infant sleep deaths have remained stubbornly unchanged for over 20 years.

Happiest Baby’s hope is that this landmark FDA authorization will support more parents and caregivers in following safe-sleep guidelines, keeping our smallest and most vulnerable citizens safely sleeping on their backs. Dr. Harvey Karp, the renowned pediatrician behind SNOO, envisions a day that SNOO is used by all babies…like a car seat for sleeping. “Just as infant seats dramatically improved child car safety, we believe SNOO will dramatically improve infant sleep safety,” he says.

What SNOO’s FDA Decision Means for You

Families across America can already rent SNOO for just dollars a day. And thousands of parents get a free SNOO rental as an employee benefit. In light of SNOO’s FDA De Novo authorization, we hope that thousands more employers will soon begin offering SNOO to families like yours! Our ultimate goal? To have insurance cover SNOO, so that it’s free to all new parents. While these things take time (breast pumps weren’t even covered by insurance until 2012), we encourage everyone to ask their employers about covering SNOO.

Disclaimer: The information on our site is NOT medical advice for any specific person or condition. It is only meant as general information. If you have any medical questions and concerns about your child or yourself, please contact your health provider.