What is a Medical Device?

The term medical device is defined by the U.S. Congress as "an instrument... which is... intended for use in the diagnosis, ... the cure, ... treatment, or prevention of disease... and which does not achieve any of its intended purposes through chemical action within or on the body...."   

Medical devices vary in complexity, ranging from implantable life-sustaining devices, such as pacemakers and defibrillators, to less sophisticated "devices," such as bedpans and gloves.  Some human tissues, including heart valve allografts, are regulated as devices, as are many device accessories, such as plastic tubing and computer software. 

Overall, more than 4% of the U.S. population has at least one implanted medical device, and some form of medical device is used for almost everyone who receives medical attention -- whether from their family physician or as a hospital in-patient.