Device Studies

Device Studies Clinical Studies

Study Description Age In/Outpatient Status
No Current Clinical Studies Available.

What is a medical device? The Food and Drug Administration considers medical devices to be:

“…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 any of it’s 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.”

Examples of medical devices include:

  • simple tongue depressors and bedpans
  • complex programmable pacemakers with micro-chip technology and laser surgical devices
  • in-vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology
  • Certain electronic radiation emitting products with medical application and claims meet the definition of medical device (include diagnostic ultrasound products, x-ray machines and medical lasers)