"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. As added by P.L.176-2021, SEC.1.