Introduction: What are medical devices?

There are various definitions of “medical devices” or, more broadly, “medical equipment.” Following the widely accepted definition advanced by the US Food and Drug Administration (USFDA), medical devices range from simple instruments such as tongue depressors and bedpans to more technologically complex pacemakers and implantable devices, but exclude pharmaceuticals. Medical devices also encompass in vitro diagnostic products, such as general-purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Specifically, the USFDA defines a medical device as

For the purpose of this chapter, we use the above definition and the terms “medical devices” and “medical equipment” interchangeably. As noted, medical devices can span several functions and therapeutic areas.