Table 4.
Regulatory Authority | Drug | Medical Device |
---|---|---|
European Union [126] | Any substance or combination of substances
|
Any instrument, apparatus, appliance, material, software, or other article […] to be used in humans for the purpose of:
|
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. |