definiens: shall have the meaning defined by the Federal Food, Drug, and Cosmetic Act, 21 UnitedStates Code § 321(h ) which reads substantially as follows, “ a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including acomponent part, or accessory which is : ( i ) recognized in the official National Formulary, or the United StatesPharmacopoeia, or any supplement to them ; ( ii ) intended for use in the diagnosis of disease or otherconditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ; or(iii ) intended to affect the structure or any function of the body of man or other animals, and which does notachieve any of its primary intended purposes through chemical action within or on the body of man or otheranimals and which is not dependent upon being metabolized for the achievement of any of its primaryintended purposes ”