medical device


medical device

FDA
Any article or healthcare product intended for use in the diagnosis of disease or other condition, or for use in the care, treatment or prevention of disease, which does not achieve any of its primary intended purposes by chemical action or by being metabolised.
 
Examples
Diagnostic test kits, crutches, electrodes, pacemakers, catheters, intraocular lens.
Medical technology
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.

medical device

Any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized Examples Diagnostic test kits, crutches, electrodes, pacemakers, catheters, intraocular lens. See Class I, II, III devices, Significant risk device, Silicone implant. Cf Nonsignificant risk.

medical device

Any health care product that is intended for the diagnosis, prevention, or treatment of disease and does not primarily work by effecting a chemical change in the bodySee also: device