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 70941
View Syllabus Download
Session Fall 2017 CPS Quarter - Second Half
Class Meeting Dates 10/30/2017 to 12/16/2017
Instructor Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 70944
View Syllabus Download
Session Fall 2017 CPS Quarter - Second Half
Class Meeting Dates 10/30/2017 to 12/16/2017
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 06
CRN 70945
View Syllabus Download
Session Fall 2017 CPS Quarter - Second Half
Class Meeting Dates 10/30/2017 to 12/16/2017
Instructor Heather Harvey
Schedule Thursday, 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 01
CRN 20900
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
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Schedule Tuesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Online
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 Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 04
CRN 20903
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
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
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