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
The U.S. Food and Drug Administration (FDA or the Agency) recommends the consistent use of terms and definitions of legal significance. In light of recent amendments to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a result of the enactment of the Safeguarding Therapeutics Act, FDA is issuing this guidance to promote clarity regarding references to the terms “device” and “counterfeit device.” In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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