The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, however, that just because a manufacturer has knowledge that health care providers prescribe or use the product for an unapproved use, does not establish a new “intended use” for the product.
Source: FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products