PLAS.4020 Medical Device Development Regulation

Id: 041942 Credits: 3-3

Description

Comprehensive and in-depth analysis of US medical device diagnostics development and approval requirements. Detailed analysis of quality assurance issues and regulatory reforms implemented under the Food and Drug Administration. Provides a step-by-step guide through the Center for Devices and Radiological Health (CRDH) investigational device exemptions, premarket approval, 510 (k) application process, and product development protocol and review processes.

Prerequisites

Level is Junior or Senior Standing Only.

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Course prerequisites/corequisites are determined by the faculty and approved by the curriculum committees. Students are required to fulfill these requirements prior to enrollment. For courses offered through online or GPS delivery, students are responsible for confirming with the instructor or department that all enrollment requirements have been satisfied before registering.