[As Amended Through P.L. 113–5, Enacted March 13, 2013]

A 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:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or
    prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

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Books for FDA

Title 21 US Code (USC) Section 321

Download “21 USC Section 321” USCODE-2012-title21-chap9-subchapII-sec321.pdf – Downloaded 580 times – 183 KB

Last Updated: 2017-01-29