GPA

3.80

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Medical devices are developed, manufactured, and distributed in a highly regulated environment. This course concerns the preclinical and clinical study design processes for obtaining FDA marketing approval for biomedical devices. Prior to marketing a medical device in the US, specific governmental approval is required dependent on the type of device and the risk associated. This course is part of a three-course series dealing with various aspect of regulatory science. Regulatory science considers the scientific and technical foundations that support the practical testing and regulations that ensure the safety and effectiveness of medical devices. This course covers the responsible conduct of clinical and preclinical research, including evaluation of device tissue interactions and how they may be studied with preclinical animal models to predict safety and performance in human clinical trials that are necessary to gain regulatory approval for marketing. In the section on ethics we will cover several topics related to responsible conduct of clinical and preclinical research, including informed consent, risk assessment and ethical decisions, IRB oversight and ethical study design.

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