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U.S. Department of Health and Human Services

Medical Devices

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When is a Baby Product Regulated by the FDA?

A baby product is considered a medical device when 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).

Medical devices, whether intended for babies or adults, are regulated by the FDA. This includes baby products if they are marketed with medical claims to cure, treat, or prevent Sudden Infant Death Syndrome (SIDS).

Below are some examples of medical claims, other than SIDS prevention, that would cause a baby product to be a medical device and regulated by the FDA:

  • Prevention of plagiocephaly (including flat head syndrome)
  • Prevention of infant suffocation
  • Relief from symptoms of gastroesophageal reflux disease
  • Relief from symptoms of colic

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.

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