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 80340
Session Spring 2016, Full-Term Session
Class Meeting Dates 04/11/2016 to 07/02/2016
Instructor Ms. Lisa Crockett
Schedule Thursday 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 80317
Session Spring 2016, Full-Term Session
Class Meeting Dates 04/11/2016 to 07/02/2016
Instructor Mr. Joel Kent
Schedule Tuesday 5:50 p.m. - 7:30 p.m.
Campus Boston Main Campus
Course Format Blended
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 80424
View Syllabus Download
Session Spring 2016, Full-Term Session
Class Meeting Dates 04/11/2016 to 07/02/2016
Instructor Ms. Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 80468
Session Spring 2016, Full-Term Session
Class Meeting Dates 04/11/2016 to 07/02/2016
Instructor Mr. Dennis Hong JD
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Term
    Feb 22, 2016 (6-week classes)
  • Spring Term
    Apr 11, 2016 (6- and 12-week classes)
    May 23, 2016 (6-week classes)

Academic Calendar

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