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# Device Definition Draft Guidance
- URL: https://www.fdaweb.com/device-definition-draft-guidance/
- Published: 2021-12-15T12:00:00.000Z
- Updated: 2026-09-14T17:25:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150774

FDA has published a draft guidance, *Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Comment, Communications, and Other Public Documents*, to promote clarity regarding references to the terms “device” and “counterfeit device.” The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/referencing-definition-device-federal-food-drug-and-cosmetic-act-guidance-regulatory-documents?utm%5Fmedium=email&utm%5Fsource=govdelivery) says that as a result of the enactment of the Safeguarding Therapeutics Act, the definition of “device” was redesignated within the Federal Food, Drug, and Cosmetic Act and a new definition of “counterfeit device” was codified within the act.