In January FDA published a controversial revision to its regulations defining a product’s “intended use” that  among other things  has raised an interesting logical outgrowth question “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can be crucial to determining whether a product is a drug or device subject to FDA oversight at all  and whether an FDA-authorized drug or device is in compliance with FDA requirements