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and Cosmetic Act (FD&C Act) as a result of the enactment of the Safeguarding Therapeutics Act, FDA is issuing this draft guidance to promote clarity regarding references to the terms “device” and “counterfeit device.” 

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.