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What is a medical device?

03 Nov
What is a medical device?

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— 

• recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, 

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 

• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes (21 U.S.C. 321(h)) 


Source: USFDA

USFDA Medical Device Regulatory guidance United States Pharmacopeia what is a medical device medical instrument
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