The US Food and Drug Administration US FDA regulates medical devices through it’s Center for Devices and Radiological Health (CDRH). CDRH defines a medical device 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 National Formulary or the United States Pharmacopoeia
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease
- intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.