Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents." FDA is issuing this guidance to promote clarity regarding references to the terms "device" and "counterfeit device" in guidance, regulatory documents, communications, and other public documents.