Jun 02, 2023  
2021-2022 University Catalog 
2021-2022 University Catalog [ARCHIVED CATALOG]

BME 56200 - Regulatory Issues Surrounding Approval Of Biomedical Devices

Credit Hours: 3.00.  Medical devices are developed, manufactured, and distributed in a highly-regulated environment. This course primarily concerns the processes for obtaining FDA marketing approval or clearance for biomedical devices. Prior to marketing a medical device in the US, a specific governmental approval or clearance is required depending on the type of device and the risk associated with the device. This course is part of a three-course series dealing with various aspects of regulatory science. Regulatory processes for class I, II, and III devices, including combination devices, are covered with specific focus on 510(k) and PMA requirements. Approval requirements in the EU, Japan and other countries will also be briefly considered. Throughout the course, emphasis will be placed on regulatory science, regulatory strategy and principles of interacting with regulatory agencies. Typically offered Spring.Credits: 3.00