Mastering and Managing the FDA Maze

Medical Device Overview

Gordon Harnack

• Publisher: ASQ Quality Press
• Year: 2014
• Print ISBN:
  9780873898874
• Edition: 2
• eBook ISBN:
  9781636940465
• Topic: Business
• Subtopic: Government & Business
• Index: Business

The number of FDA regulations and the agency's increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm's employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

Table of contents

• Cover
• Title page
• CIP data
• Contents
• Figures and Tables
• Acknowledgments
• What is New?
• Introduction
• Chapter 1_FDA Laws, Regulations, and Medical Device Oversight
• Chapter 2_FDA Inspections
• Chapter 3_Quality System Requirements, Management Responsibilities, and Personnel
• Chapter 4_Design Controls
• Chapter 5_Document Controls
• Chapter 6_Purchasing Controls
• Chapter 7_Identification and Traceability
• Chapter 8_Production and Process Controls
• Chapter 9_Acceptance Activities
• Chapter 10_Nonconforming Product
• Chapter 11_Corrective and Preventive Action
• Chapter 12_Statistical Techniques
• Chapter 13_Device Master Record (DMR)
• Chapter 14_Labeling and Packaging
• Chapter 15_Handling, Storage, and Distribution
• Chapter 16_Installation and Servicing
• Chapter 17_Records—General Requirements, Device History Record (DHR), and Quality System Record (QSR)
• Chapter 18_Complaint Files
• Chapter 19_Unique Device Identification (UDI) System Including Applicable Parts of 21 CFR 830 and 21 CFR 801
• Chapter 20_Medical Device Reporting
• Chapter 21_Medical Devices—Reports of Corrections and Removals
• Chapter 22_Quality Audit
• Appendices
• Appendix A
• Appendix B
• Appendix C
• Appendix D
• Appendix E
• Appendix F
• References and List of FDA Offices
• Acronym List
• Glossary
• Index