35 Ill. Adm. Code 211.3705
Medical Device
Section 211.3705
Medical Device
"Medical Device" means, for purposes of 35 Ill.
Adm. Code 218.187 and 219.187, an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent or other similar article, including any component
or accessory, that meets one or more of the following conditions:
a) it is
intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease;
b) it is intended to
affect the structure or any function of the body; or
c) it is
defined in the National Formulary or the United States Pharmacopeia, or any
supplement to them.