FDA Grants De Novo Authorization for Infant Sleeping Device to Reduce the Risk of SIDS

The FDA has granted De Novo authorization for Happiest Baby’s SNOO Smart Sleeper, a product designed to keep babies positioned on their backs while sleeping to reduce the risk of sudden infant death syndrome (SIDS).

The SNOO Smart Sleeper is a bassinet into which the baby is fastened with a sleeping sack. The device provides gentle rocking and soothing sounds, increasing the speed of rocking and sound level when the baby fusses.

The device can reduce unsafe stomach sleeping by more than 90 percent, the company said.

The FDA classified the SNOO Smart Sleeper as a Class II device to be used for infants from birth to six months of age, who are not yet able to roll over consistently.

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