When is a Baby Product Regulated by the FDA as a medical device?
A baby product is considered a medical device if claims to cure, treat, prevent, or reduce a disease or condition are made in the product’s labeling, packaging, or advertising (ref. section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act). Baby products that do not meet the definition of “device” under section 201(h) of the FD&C Act may be regulated by another federal agency, for example the Consumer Product Safety Commission.
SIDS Prevention Claims
Some retail baby products are being marketed with claims that the products prevent Sudden Infant Death Syndrome (SIDS). The National Institute of Child Health and Human Development defines SIDS as "the sudden, unexplained death of a baby younger than 1 year of age that doesn’t have a known cause even after a complete investigation including performance of a complete autopsy, examination of the death scene, and review of the clinical history."
To date, the FDA has not 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. In fact, baby products with such claims can actually pose a suffocation risk to infants. As a result, the agency cautions parents and caregivers not to purchase or use baby products with claims to prevent or reduce the chance 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 sleep 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.