The article provides an overview of the regulatory provisions related to the definition of a medical device as set forth by the existing legislation. 

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to referencing the definition of “device” in the Federal Food, Drug, and Cosmetic (FD&C) Act in guidance, regulatory documents, communications, and other public documents. The document provides additional clarifications regarding the use of the term “device”, as well as recommendations to be considered to ensure correct interpretation. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations, so in case of any discrepancies with the provisions of the underlying regulations, the latter should prevail. 

The present document describes the approach to be followed to ensure consistency in the interpretation of the terms “device” and “counterfeit device”. 


Regulatory Background 

The definition of “device” as outlined in the FD&C Act is used to determine the regulatory nature of the products. Later the regulation was supplemented with the definition of “counterfeit device”. According to the said Act, the term “device” which applies to medical devices is defined as follows:

The term “device” […] means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including any component, part, or accessory, which is –

  • Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
  • 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
  • Intended to affect the structure or any function of the body of man or other animals, and 

Which does not achieve its primary intended purpose 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 purpose. The term “device” does not include software functions excluded under section 520(o). 

Thus, when determining the regulatory nature of the product subject to review, one should assess whether it meets the above definition. 

The existing regulations also provide a definition of the term “counterfeit device” which stands for 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 manufactured, processed, packaged, 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 term was initially introduced by the Safeguarding Therapeutics Act amending the FD&C Act which, however, does not introduce any changes to the definition of a “device”. It is also stated that the existing legislation provides the refusal of admission for counterfeit devices in the country, authorizing the FDA to destroy such devices. The appropriate policy was implemented by the device of separate documents and falls outside the scope of the present document. 

The present document is intended to explain the approach the authority will apply when referencing the terms described herein when issuing new documents, including guidelines and regulations. 

References to the Term “Device” 

The references to the term “device” contained in section 201(h) of the FD&C Act are commonly used in the various documents and communications issued by the FDA. Hence, all the references to the “device” made by the FDA should be construed as references to the said definition, apart from cases when there is a reference to the counterfeit device. The same approach applies, for instance, concerning regulatory policies whereby the authority informs about its decision not to enforce certain regulatory requirements and controls concerning specific medical devices and types thereof. The authority additionally emphasizes that even in case a counterfeit medical device meets a definition of a device set forth under the FD&C Act, the policies issued by the authority should not be applied due to the differences in the regulatory status of such products. 

The authority further explains that any references to the “device” should be considered references to the aforementioned section 201(h) of the FD&C Act which defines a medical device, unless otherwise explicitly stated. This approach is intended to ensure consistency in the interpretation of documents the authority may issue from time to time. However, it is also stated that the references could be either as a direct reference to the said section or as a general use of the term “device”. In certain cases, the authority may also find it reasonable to refer to a specific subparagraph of the said section – for instance, when this is necessary to emphasize the way the device operates. At the same time, in both cases, the references are presumed to be provided to the same definition, and should not be considered to be different. 


Incoming Documentation 

According to the guidance, the authority expects medical device manufacturers and other parties involved in operations with medical devices to use the said terms in a way FDA use them. This applies to any documents the industry representatives may submit to the authority from time to time, e.g., premarket submissions, reports, inquiries, etc. The authority encourages all the parties involved to use the same approach to ensure correct interpretation. 

In summary, the present FDA guidance describes the approach the authority applies when making references to the definition of a medical device set forth under the existing legislation. The document explains the ways such references could be provided, and also clarifies the aspects related to counterfeit products. 



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