19315 Regulatory Submissions: Devices and Diagnostics

X400.022 NATSC

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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.

Prerequisite(s):

"Regulation of Medical Devices and Diagnostics" or equivalent experience.

Applies Towards the Following Certificate(s) & Award(s):

Certificate Program in Regulatory Affairs

Sections:

19315 - 008 Regulatory Submissions: Devices and Diagnostics

Status: Available

Section Note(s):Early Enrollment Fee: ($774 through Jan. 6).
(3 no meetings TBA).
Please note class end time is 9:15 pm.
Details for ordering your required textbook at a discounted price will be included on your enrollment receipt.
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.
Note: In order to obtain maximal benefit, this hands-on course requires substantial out-of-class work on a submission project, where you will be crafting a 510K. Please plan your course schedules accordingly.

For Credit 2.5 Units
Thu 6:00PM to 9:30PM
Jan 20, 2011 to Mar 31, 2011
Number of Sessions: 8

Required Text(s): Medical Device Development: Regulation and Law, Jonathan S. Kahan, Partner, Paraxel International Corp., 2nd edition 2009, ISBN 1-882-61592-1. For student discount on textbook and ordering instructions, see enrollment receipt.

Recommended Text(s): None

Tuition:	$860.00
Early Enrollment	$774.00

Method of Instruction: CLASSROOM
Campus: SANTA CLARA

Instructor(s):

CRAIG J. COOMBS, RAC.