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5.00 RAC

Medical Devices: US Regulations

This course is intended to provide a basic overview of US medical device regulation.


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5.00 RAC

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This course is intended to provide a basic overview of US medical device regulation. It covers a wide range of issues, from the history of medical device regulation to the steps required to submit an application to the US Food and Drug Administration (FDA) for approval (or clearance) to market a...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design