Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation.
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.”
November 30, 1983 – May 20, 1984
The FDA has never cleared or approved a 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.
Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS include:
- baby monitors,
- crib tents,
- crib bedding, including bumpers and blankets, and
- infant positioners.
Current research shows that the best way to reduce the chance of SIDS is to create a safe sleep environment for a baby: alone, in their own sleeping space with no other people in the crib or bassinet; on their backs on a firm sleep surface; and in a crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects.
The purpose of this website is to:
- help manufacturers of baby products understand and comply with the FDA laws and regulations for medical devices and
- educate parents and caregivers about the risks of using over-the-counter baby products marketed with SIDS medical claims.
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