Mastering and Managing the FDA Maze : Medical Device Overview, 2nd Edition

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

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

Appendix A : Part 820 - Quality System Regulation
Appendix B : Part 801 - Labeling
Appendix C : Part 830 - Unique Device Identification
Appendix D : Part 803 - Medical Device Reporting
Appendix E : Part 806 - Medical Devices, Reports of Corrections and Removals
Appendix F : Part 807 - Establishment Registration and Device Listing for Manufacturers and Distributors of Device
References and List of FDA Offices
Acronym List
Glossary
Index