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U.S. Department of Health and Human Services

Medical Devices

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FDA Actions

The FDA is taking regulatory action against manufacturers of baby products with medical claims that do not have FDA approval or clearance.

In March 2000, the FDA issued a public letter telling manufacturers and distributors of baby products, specifically baby mattresses and positioners, that making medical claims associated with Sudden Infant Death Syndrome (SIDS) causes these products to be medical devices.

More recently, in September 2010, the FDA and the Consumer Product Safety Commission issued a joint warning against using infant sleep positioners because of suffocation risk.

In addition, the FDA is collaborating with the other agencies to educate the public about the risks associated with over-the-counter baby products marketed with SIDS prevention medical claims, and to help manufacturers understand and comply with FDA laws and regulations for medical devices.