Abstract
Medical devices are health-care products distinguished from drugs for regulatory purposes in most countries throughout the world based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device
“...means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease...or intended to affect the structure or any function of the body...and which does not achieve its primary intended purposes through chemical action within or on the body....”1
This broad definition of medical devices encompasses literally tens of thousands of different types of health-care products, including in vitro diagnostics.
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Witkin, K.B. (1998). Clinical Trials in Development and Marketing of Medical Devices. In: Witkin, K.B. (eds) Clinical Evaluation of Medical Devices. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-4757-2756-2_1
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DOI: https://doi.org/10.1007/978-1-4757-2756-2_1
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