Medical Device Development: A Regulatory Overview

RGA 6202 4 Quarter Hours
Course Level Graduate
Description Analyzes U.S. medical device development and approval requirements. Features detailed analysis of quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act (FDAMA), in addition to providing a step-by-step guide through the Center for Devices and Radiological Health (CDRH). Covers CDRH's reengineering initiatives and evolving investigational device exemptions, premarket approval, 510(k) application process, and product development protocol and review processes. Provides practical, in-depth analyses on how emerging developments and trends are reshaping medical device regulation in the United States. Offers students an opportunity to demonstrate an appreciation of the subjective and interpretive aspects of the regulations and an ability to think critically about the interaction between regulatory and development processes. Prereq. RGA 6100.

Course Sections

Section 01
CRN 20429
View Syllabus Download
Session Winter 2015, Full-Term Session
Class Meeting Dates 01/05/2015 to 03/28/2015
Instructor Dr. Irina Kulinets
Schedule Wednesday 5:50 p.m. - 8:30 p.m.
Campus Boston Main Campus
Course Format On Ground
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 02
CRN 20430
Session Winter 2015, Full-Term Session
Class Meeting Dates 01/05/2015 to 03/28/2015
Instructor Ms. Lisa Crockett
Schedule Wednesday 5:50 p.m. - 8:30 p.m.
Campus Boston Main Campus
Course Format On Ground
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 03
CRN 20431
Session Winter 2015, Full-Term Session
Class Meeting Dates 01/05/2015 to 03/28/2015
Instructor Mr. Robert Ezzell
Schedule Wednesday 5:50 p.m. - 8:30 p.m.
Campus Boston Main Campus
Course Format On Ground
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 20730
View Syllabus Download
Session Winter 2015, Full-Term Session
Class Meeting Dates 01/05/2015 to 03/28/2015
Instructor Dr. Irina Kulinets
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 20731
View Syllabus Download
Session Winter 2015, Full-Term Session
Class Meeting Dates 01/05/2015 to 03/28/2015
Instructor Ms. Karin Desjardins
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Term
    Jan 5, 2015 (12- and 6-week classes)
    Feb 17, 2015 (6-week classes)
  • Spring Term
    Apr 6, 2015 (12- and 6-week classes)
    May 18, 2015 (6-week classes)

Academic Calendar

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