FDA Definition of a Device

A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory. It is recognized in the official National Formulary, or the U.S. Pharmacopeia, or any supplement to them. It is intended for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or the diagnosis of conditions other than diseases such as pregnancy, to affect the structure or any function of the body of man or other animals.

Devices are:

  • an integral and subordinate part of a procedure;
  • used for one patient only;
  • surgically implanted or inserted; and,
  • remain with that patient after the patient is released.

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