Medical device

A medical device refers to any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s).

Specific medical purposes include diagnosis, prevention, monitoring, treatment, or alleviation of disease injury; investigation, replacement, modification, or support of the anatomy or of a physiological process including supporting or sustaining life and control of conception. A medical device does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Diagnostic ultrasound products, x-ray machines, and medical lasers are also medical devices.

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U.S. Food and Drug Administration (FDA): How to Determine if Your Product is a Medical Device
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U.S. Food and Drug Administration (FDA): Medical Device Overview