Cost & Quality Problems

Medical Devices

For the last few years, pharmaceuticals have taken center stage in the debate around rising health care costs, but medical devices are an industry with many parallels to pharmaceuticals. Like drugs, devices are regulated by the FDA; tremendous innovation has helped patients lead longer, healthier lives but inadequate oversight and hidden pricing of devices may be contributing to cost growth and safety concerns.

What are Medical Devices?

The U.S. Food and Drug Administration (FDA) defines a medical device as “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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