Addendum

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Chapter: Pharmacovigilance: Surveillance for Medical Devices - USA

A medical device is defined as an instrument, appa-ratus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:


ADDENDUM

A medical device is defined as an instrument, appa-ratus, 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 US Pharmacopoeia, 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 any of its primary intended purposes (Section 201 of the Act, Title 21 US Code $321).

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