Illinois Administrative Code
Title 35 - ENVIRONMENTAL PROTECTION
Part 211 - DEFINITIONS AND GENERAL PROVISIONS
Subpart B - DEFINITIONS
Section 211.3705 - Medical Device
Universal Citation: 35 IL Admin Code ยง 211.3705
Current through Register Vol. 48, No. 38, September 20, 2024
"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.
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