NYSDA Publications

FDA Issues Final Guidance Defining "Device"

The United States Food and Drug Administration (FDA) has issued the final guidance: Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.  With the enactment of the Safeguarding Therapeutics Act (P.L. 116-304) in January 2021, Congress redesignated the definition of “device” and added a new definition of “counterfeit device” within section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.  This final guidance is intended to provide clarity on references to the terms “device” and “counterfeit device” (as well as existing references to section 201(h) of the FD&C Act) in guidance, regulatory documents, communications, and other documents for the FDA’s staff, industry, and other stakeholders.  FDA’s implementation of new administrative destruction authorities under the Safeguarding Therapeutics Act is the subject of a separate FDA rulemaking (see 87 FR 60947).


If you have questions about this final guidance, contact the Division of Industry and Consumer Education.