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Regulatory Requisites for Registration Process of Medical Devices in United StatesBy Sharath S., S.B. Puranik, Mohammed Mubeen Ahmed
Abstract: A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States 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, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 1, 2017 · pp. 31–41 Read article →