RGA 6202 — Medical Device Development: A Regulatory Overview

4 semester hoursGraduateLecture

Analyzes U.S. medical device engineering development, marketing approval, and commercialization compliance requirements from scientific, technical, and engineering-based perspectives. Features analysis of quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act (FDAMA). Provides 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. Offers practical, in-depth analyses and didactic instruction on how emerging technical trends and the application of statistical modeling to analyze product complaints are reshaping medical device regulation in the United States. Offers students an opportunity to learn how to think critically about the interaction between regulatory and development processes.

Prerequisites

• all of:
  • BTC 6210 (min C-) (may be taken concurrently)
  • RGA 6001 (min C-) (may be taken concurrently)

Unlocks

RGA 6203, RGA 6204, RGA 6205, RGA 6210, RGA 6215, RGA 6217, RGA 6219, RGA 6223, RGA 6224, RGA 6233, RGA 6235, RGA 6243, RGA 6308, RGA 6370, RGA 6410, RGA 6415, RGA 6420, RGA 6435, RGA 6440, RGA 6461, RGA 6475, RGA 6490, RGA 6500, RGA 6630, RGA 6650, RGA 6680, RGA 6690

Courses that list RGA 6202 in their prerequisites.

Links

Official catalog (RGA course descriptions) · All RGA courses · Plan it at numap.app

More

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 "retired": true,
 "retiredSince": "2026-09-03"
}