FDA clarifies definition of devices vs. counterfeit devices

The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act. The document – published 10 November – is intended to delineate devices from counterfeit devices, but does not include enforcement discretion for counterfeit devices.
“With the enactment of the Safeguarding Therapeutics Act in January 2021, Congress redesignated the definition of ‘device’ and added a new definition of ‘counterfeit device’ within section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act,” according to the FDA. “This final guidance is intended to provide clarity on references to the terms ‘device’ and ‘counterfeit device’ (as well as existing references to section 201(h) of the FD&C Act) in guidance, regulatory documents, communications, and other documents for the FDA’s staff, industry, and other stakeholders.” The guidance is entitled Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.
Current law now defines a device as an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent which is recognized in the official National Formulary, or the United States Pharmacopeia. The device must be used to diagnose a disease or condition, or to cure, mitigate, treat or prevent a disease. The new language also excludes certain software functions as devices.

Perhaps the most important part of the update to the FD&C Act is the definition of counterfeit products.
“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,” the act now states.
The new definitions give the FDA authority to destroy counterfeit devices; however, the agency noted that a separate rulemaking process is required.

“In addition, under the Safeguarding Therapeutics Act, articles that appear to be counterfeit devices are subject to refusal of admission into the United States,” the FDA clarified. “The Safeguarding Therapeutics Act also grants FDA new authority to destroy certain devices refused admission. These additional amendments to the FD&C Act are being implemented through separate policy documents and are beyond the scope of this guidance.”
The FDA said it expects to receive premarket submissions, reports, and other communications from sponsors and other stakeholders that use the term device. The agency says it will use the definition of “device” as defined in the guidance moving forward and encourages “stakeholders to align with the recommendations described herein to the extent practicable.”


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