Meeting Details

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The Basics of 510(k) and Working With FDA
Imperial Riding School Renaissance Vienna Hotel
Ungargasse 60 1030 Wien Austria
November 13-14, 2017
10.00 RAC

After this program, participants will be able to:

  • Describe the regulatory framework behind FDA’s classification of medical devices
  • Develop the underlying data and documentation needed to support a 510(k) submission
  • Prepare a 510(k) submission with all required sections
  • Interact confidently with FDA during the 510(k) review process
  • List Price: $1,250.00
  • Member Price: $1,150.00
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Most medical devices in the U.S. today are marketed under the premarket notification 510(k) authorities of the U.S. Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most types of Class II devices in the United States, you need to submit a 510(k) submission to FDA...
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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