definiens: shall have the meaning defined by the Federal Food, Drug, andCosmetic Act, 21 United States Code § 321(h ) which reads substantially as follows, “ amedical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is : ( i ) recognized in the official National Formulary, or the UnitedStates Pharmacopoeia, or any supplement to them ; ( ii ) intended for use in thediagnosis of disease or other conditions, or in the cure, mitigation, treatment, orprevention of disease, in man or other animals ; or ( iii ) intended to affect the structureor any function of the body of man or other animals, and which does not achieve anyof its primary intended purposes through chemical action within or on the body of manor other animals and which is not dependent upon being metabolized for theachievement of any of its primary intended purposes ”