Baby Products with SIDS Prevention Claims
A common medical claim being made is the prevention of Sudden Infant Death Syndrome (SIDS). The National Institute of Child Health and Human Development defines SIDS as “the sudden death of an infant under one year of age, which remains unexplained after a thorough case investigation, including performance of a complete autopsy, examination of the death scene, and review of the clinical history.”
The FDA has never cleared or approved any baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS. Click HERE for more information.