The 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. 

The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance, regulatory documents, communications and other public 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). However, 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 upon enactment of the Safeguarding Therapeutics Act in January 2021.

Per the final guidance, whether FDA cites to section 201(h) or to 201(h)(1) of the FD&C Act, FDA’s intent should not be understood to be any different. “In either case, we are intending to refer readers to the definition of ‘device’ contained in paragraph (1) of section 201(h) of the FD&C Act, or to otherwise apply policies to or reference devices that meet the definition in paragraph (1), but not to counterfeit devices defined in paragraph (2).”

The terms as defined in Section 201(h) of the FD&C Act are as follows:

(h)(1) The term “device” (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).

(2) The term “counterfeit device” means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.

Download the Final Guidance here.