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. 2021 Feb 3;14(4):706. doi: 10.3390/ma14040706

Table 4.

EU and US regulatory authority definitions of drug and medical device (emphasis added).

Regulatory Authority Drug Medical Device
European Union [126] Any substance or combination of substances
  • having properties for treating or preventing disease in human beings or;

  • may be used in or administered to human beings with view to restore, correct, modify physiological function

by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Any instrument, apparatus, appliance, material, software, or other article […] to be used in humans for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,

  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury/handicap

  • investigation, replacement, modification of the anatomy; control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
FDA [127] (A) articles recognized in the official United States Pharmacopoeia […]; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; […] an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, […]
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.