IC 24-5-26.5-6: "Medical device"

Sec. 6. As used in this chapter, "medical device" refers to an instrument, an apparatus, an implement, a machine, a contrivance, an implant, an in vitro reagent, or another similar or related article, including a component part or accessory:

(1) that is recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them;

(2) that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in a human being or an animal; or

(3) that:

(A) is intended to affect the structure or any function of the body of a human being or an animal;

(B) does not achieve its primary intended purpose through chemical action within or on the body of a human being or an animal; and

(C) is not dependent upon being metabolized for the achievement of its primary intended purpose.