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FAQ:
Q: Are sleep positioners safe for babies?
A: You can do your part to keep your baby safe by not using sleep positioners. You can report an incident or injury from an infant sleep positioner to the FDA’s MedWatch program. And you can find more advice about baby products on the FDA’s website.
Q: Are infant positioners FDA approved for SIDS?
A: The FDA had previously cleared some infant positioners for GERD or flat head syndrome. In 2010, the FDA became aware of infant positioners being marketed with SIDS claims and notified manufacturers to stop marketing these devices and submit information to support FDA clearance.
Q: Are sleep positioners regulated by the FDA?
A: Sleep positioners that do not meet the definition of a medical device may be regulated by the Consumer Product Safety Commission. Some types of sleep positioners can feature raised supports or pillows (called “bolsters”) that are attached to each side of a mat, or a wedge to raise a baby’s head.
Q: Are inclined sleep products safe for infants?
A: CPSC hired independent expert Erin Mannen, Ph.D., a mechanical engineer specializing in biomechanics at the University of Arkansas for Medical Sciences, to conduct infant testing to evaluate the design of inclined sleep products. Dr. Mannen found that none of the inclined sleep products her team tested is safe for infant sleep.