3 credits
Spring 2025 Lecture Distance Learning Upper Division
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.
Learning Outcomes1Use the appropriate regulatory classification and pathway for any medical device in the U.S.
2Describe the significance of each major component of a 510(k) submission.
3Describe the significance of each major component of a PMA submission.
4Develop awareness for the need to seek country-specific expertise to prepare submissions for countries outside the U.S.
5Select the appropriate messages and clearly present, in both oral and written communication, in a mock FDA meeting.
6Identify contents of a CER and know the strategy for writing a CER.
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made by Purdue students.