Regulation of Medical Devices

Abstract The Regulation and approval process of medical devices are different from regulation and approval process of medicinal products. For instance, in the US, medical devices are regulated by the FDA branch called the center for devices and radiological health (CDRH). Some of the differences in approach employed in evaluating medical devices depends on the functionality, utility and effectiveness. For example, in the medicinal product’s phase 1 clinical trials, researcher’s objective accesses tolerable dose for an investigational medicinal product. Contrary to device evaluation, dosage assessment is not a possible option with a clinical trial involving an investigational medical device. Rather, the evaluation research for medical devices depend on whether the device performance meets the stated claim of the device utility and function. Moreover, the level of risks and evaluation temerity of a medical device assessment depends on the class of the device. Medical devices are classified into three classes; class

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