美国体外诊断试剂是按什么管理的
医疗器械 in vitro diagnostics (ivds) meet the definition of a device under the act. section 201(h) of the act defines a device as:“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which **—(1) recognized in the official national formulary, or the united states pharmacopeia, or any supplement to them,(2) intended for use in the diagnos** of d**ease or other conditions, or in the cure, mitigation, treatment, or prevention of d**ease, in man or other animals, or(3) intended to affect the structure or any function of the body of man or other animals, andwhich does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which ** not dependent upon being metabolized for the achievement of its primary intended purposes.” 21 u.s.c. 321(h) (emphas** added). 20210311