Regulations Regarding “Intended Uses”

Document number 2020-20437. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product "intended use" regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and clarity to regulated industry and other stakeholders.