Companies can inadvertenly fall under the FDA’s authority by how they market themselves. Medical devices include any claim to “cure, treat, or prevent a disease or condition.” Marketing materials that make this claim may take an ordinary retail product and convert into a medical device regulated by the FDA.
A recent example of this comes from the FDA’s warning about baby products making Suddent Infant Death Syndrome (SIDS) prevention claims.
From the FDA
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.”
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:
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