Sec. 7. As used in this chapter, "medical device" means an instrument, an apparatus, an implement, a machine, a contrivance, an implant, an in vitro reagent, a tool, or other similar or related article, including a component part or an accessory: (1) required under federal law to bear the label "Caution: Federal law requires dispensing by or on the order of a physician"; or (2) that is defined by federal law as a medical device and that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in humans or animals or is intended to affect the structure or any function of the body of humans or animals, that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or animals, and that is not dependent upon being metabolized for achievement of its principal intended purposes.
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