Introduction to Food and Drug Administration Medical Device Regulation

RGA 6001 2 Quarter Hours
Course Level CPS - Graduate
Description Provides students with an overview of the medical device development process, and the function of the Food and Drug Administration (FDA) as it relates to device product commercialization. Through course work and participation, the course offers students an opportunity to develop an understanding of fundamental medical device regulatory affairs from a U.S.-centric perspective. Topics include a review of the historical development of significant U.S. medical device legislation, including the 1976 Medical Device Amendments Act. In addition, the subject of Quality System Regulations (QSRs) as they relate to device product design, clinical development, and compliance are introduced.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

Section 02
CRN 20901
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Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Instructor Heather Harvey
Schedule Tuesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 03
CRN 20902
View Syllabus Download
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Schedule Wednesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 04
CRN 20903
View Syllabus Download
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Instructor Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 21069
View Syllabus Download
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Schedule Thursday, 5:50 pm - 8:30 pm
Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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