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GUIDANCE DOCUMENT

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 November 2022

Final
Docket Number:
FDA-2021-D-0997
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center 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.


Submit Comments

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:

Dockets Management
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.

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