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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA is issuing this guidance to clarify our approach for referencing the terms “device” and “counterfeit device” in FDA documents. For many years, the definition of “device” has been codified at section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Upon the enactment of the Safeguarding Therapeutics Act in January 2021, the definition of device was redesignated to section 201(h)(1) of the FD&C Act, and the new term “counterfeit device” and its definition were designated at section 201(h)(2) of the FD&C Act. FDA is issuing this guidance to provide clarity on how we intend to reference the terms “device” and “counterfeit device” and how we intend to interpret existing references to section 201(h) of the FD&C Act, in guidance, regulatory documents, communications, and other public documents.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0997.