Regulatory Requisites for Registration Process of Medical Devices in United States

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, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of 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".

Keywords: Medical device, registration, US FDA

Cite this Article

Sharath S, Puranik SB, Mohammed Mubeen Ahmed. Regulatory Requisites for Registration Process of Medical Devices in United States. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 31–41p.