Sep 27, 2022  
2021-2022 Graduate Catalog 
    
2021-2022 Graduate Catalog [Not Current Academic Year. Consult with Your Academic Advisor for Your Catalog Year]

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ECE 6375 - Medical Devices Law, Regulation, and Ethics

Credit Hours: 3
Lecture Contact Hours: 3   Lab Contact Hours: 0
This course provides a practice-oriented introduction to the U.S. Coordinated Framework for regulating fast-emerging technologies such as smart robots, artificial intelligence software, precision medicine, neurotechnologies and advanced prosthetics, genomic testing and gene-edited life forms. Collectively, these technologies promise to revolutionize healthcare, enhance human capabilities, and address nagging environmental and social problems such as world hunger, yet they threaten to displace workers and disrupt entire economic sectors. The course offers a manageable, highly practical survey of key US safety regulations administered by agencies including the Food and Drug Administration, the Environmental Protection Agency, the U.S. Department of Agriculture. It also samples the difficult ethical, privacy, societal, and human rights issues these technologies are already raising. The course is suitable for engineers and scientists with no prior legal experience who want a practical introduction to how to navigate the federal regulatory frameworks that affect development and commercialization of their innovations. It is suitable for law students wishing a highly practical account of the challenges entrepreneurs/clients face in moving products through the U.S. biotechnology regulatory framework.
Repeatability: N

Additional Fee: Y Fee Type Y



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