The U.S. Food and Drug Administration (FDA) recently issued a guidance document to clarify the agency’s use of the term “device” in its regulations.
The guidance, titled “Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents,” is intended to clarify recent amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act prompted by the enactment of the 2021 federal Safeguarding Therapeutics Act.
In brief, the Safeguarding Therapeutics Act defined a new term, “counterfeit device,” applicable to any device that uses proprietary names, markings, or manufacturing processes without prior authorization. Devices deemed counterfeit devices are subject to refusal of admission into the U.S., and the Act also empowers the FDA to destroy any such devices that have been unlawfully admitted.
To help avoid potential confusion about the difference between “device” and “counterfeit device,” the FDA amended FD&C Act to include a new definition for counterfeit devices consistent with the Safeguarding Therapeutics Act. The amended FD&C Act also clarifies the FDA’s use of the terms “device” and “counterfeit device” in its regulatory documents and other FDA communications. The FDA’s guidance serves to explain these changes to facilitate compliance efforts by device manufacturers.
Guidance documents issued by the FDA represent only the current thinking of the agency and do not establish legally enforceable requirements or responsibilities.