According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the Safeguarding Therapeutics Act of 2021.
As part of this guidance, FDA clarifies how we intend to use the terms "device" and "counterfeit device" in guidance, regulatory documents, communications, and other public documents, and how we intend to interpret existing references to section 201(h) of the FD&C Act.
In short this guidance, FDA clarifies our approach to referencing terms such as "device" and "counterfeit device" in FDA documents.
The term “device” 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 “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.
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