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 01
CRN 20900
View Syllabus Download
Session Winter 2018 CPS Quarter - First Half
Class Meeting Dates 01/08/2018 to 02/17/2018
Instructor Heather Harvey
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 02
CRN 20901
View Syllabus Download
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
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 05
CRN 20904
View Syllabus Download
Session Winter 2018 CPS Quarter - First Half
Class Meeting Dates 01/08/2018 to 02/17/2018
Instructor Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 21069
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
Section 07
CRN 21084
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 11/30/-0001 to 11/30/-0001
Campus Seattle Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 08
CRN 21086
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 11/30/-0001 to 11/30/-0001
Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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