UCSC Ext. Regulatory Submissions: Diagnostics and Medical Devices, Jan. 21 – March 18, 2010 Course Description: This course is designed to provide individuals who already have a foundation in medical device terminology, classification, and pathways to market, with opportunities to gain a greater exposure to key medical device submissions. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents, and style guides to write portions of key medical device submissions that both comply with the requirements and are clear to the reviewers. Students explore the content and process of medical device submissions, as well as gain insight into timelines, important strategic considerations and business impacts. Topics include IDE; 510(k) (including unique features of in vitro diagnostics); PMA; brief coverage of HDE and PDP; combination products; foreign manufacturers filing in the U.S.; and global submissions. Instructor: Craig J. Coombs, RAC Dates and Times: Thu 6:00PM to 9:30PM Jan 21, 2010 to Mar 18, 2010 Number of Sessions: 8 Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara Tuition: $725 (Early enrollment - $652.50 See details at www.ucsc-extension.edu/biosciences
