Baby Products with SIDS Prevention Claims
MedSun: Newsletter #66, November 2011
FDA Center for Devices and Radiological Health
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, mattresses, crib tents, pillows, crib bedding, including bumpers and blankets, and infant positioners. Because of these claims, these baby products are medical devices, subject to FDA regulation.
Baby Products with SIDS Prevention Claims. FDA Center for Devices and Radiological Health. October 18, 2011.