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 80478
Session Spring 2015, Full-Term Session
Class Meeting Dates 04/06/2015 to 06/27/2015
Instructor Dr. Irina Kulinets
Schedule Monday 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 80443
Session Spring 2015, Full-Term Session
Class Meeting Dates 04/06/2015 to 06/27/2015
Instructor Mr. Joel Kent
Schedule Monday 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 80637
Session Spring 2015, Full-Term Session
Class Meeting Dates 04/06/2015 to 06/27/2015
Instructor Dr. Leslie S Schnoll
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 80723
Session Spring 2015, Full-Term Session
Class Meeting Dates 04/06/2015 to 06/27/2015
Instructor Ms. Karin Desjardins
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Spring Term
    Apr 6, 2015 (12- and 6-week classes)
    May 18, 2015 (6-week classes)

Academic Calendar

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