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Describes the regulatory approach for medical device approval in the U.S., highlighting its implications on safety and quality.
The United States is the main therapeutic gadget showcase on the planet, representing over 40% of all social insurance spending around the world. The regulation of medical device varies from country to country. The medical device approval in U.S is examined closely by its regulatory body which is discussed. It consists of different stages for safe and efficient regulatory strategy. This article mainly focuses on elaborate study on marketing approval of medical device in U.S. FDA (Food and Drug Administration) is the regulatory body which is accountable for assessing and regulating the safety and quality of medical device and other health products in U.S.
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Janarthanan et al. (2020) studied this question.
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