Mastering and Managing the FDA Maze : Medical Device Overview.

Cover
Title page
CIP data
Contents
Figures and Tables
Acknowledgments
What is New?
Introduction
Chapter 1_FDA Laws, Regulations, and Medical Device Oversight
Scope
FDA Laws
FDA Regulations
FDA Medical Device Oversight
Chapter 2_FDA Inspections
Scope
FDA Inspections
Chapter 3_Quality System Requirements, Management Responsibilities, and Personnel
Scope
Quality System
Subpart B-Quality System Requirements
FDA Inspection of Quality System Requirements
Chapter 4_Design Controls
Scope
Design Controls
FDA Inspections of Design Controls
Chapter 5_Document Controls
Scope
Document Controls
FDA Inspection of Document Controls
Chapter 6_Purchasing Controls
Scope
Purchasing Controls
FDA Inspection of Purchasing Controls
Chapter 7_Identification and Traceability
Scope
Identification and Traceability
FDA Inspection of Identification and Traceability
Chapter 8_Production and Process Controls
Scope
Production and Process Controls
FDA Inspection of Production and Process Controls
Chapter 9_Acceptance Activities
Scope
Acceptance Activities
FDA Inspection of Acceptance Activities
Chapter 10_Nonconforming Product
Scope
Nonconforming Product
FDA Inspection of Nonconforming Product
Chapter 11_Corrective and Preventive Action
Scope
Corrective and Preventive Action
FDA Inspection of Corrective and Preventive Action
Chapter 12_Statistical Techniques
Scope
Statistical Techniques
FDA Inspection of Statistical Techniques
Chapter 13_Device Master Record (DMR)
Scope
Device Master Record (DMR)
FDA Inspection of the Device Master Record
Chapter 14_Labeling and Packaging
Scope
Labeling
Device Labeling
Subpart K-Labeling and Packaging Control
FDA Inspection of Labeling
Packaging.

FDA Inspection of Packaging
Chapter 15_Handling, Storage, and Distribution
Scope
Handling
FDA Inspection of Handling
Storage
FDA Inspection of Storage
Distribution
Subpart L-Distribution
FDA Inspection of Distribution
Chapter 16_Installation and Servicing
Scope
Installation
FDA Inspection of Installation
Servicing
FDA Inspection of Servicing
Chapter 17_Records-General Requirements, Device History Record (DHR), and Quality System Record (QSR)
Scope
Records
Subpart M-General Requirements
FDA Inspection of Records-General Requirements
Subpart M-Device History Record (DHR)
FDA Inspection of Device History Record
Quality System Record
FDA Inspection of the Quality System Record
Chapter 18_Complaint Files
Scope
Complaint Files
FDA Inspection of Complaint Files
Chapter 19_Unique Device Identification (UDI) System Including Applicable Parts of 21 CFR 830 and 21 CFR 801
Scope
Unique Device Identification
FDA Inspection of Unique Device Identification
FDA Inspection of Labeling
FDA Accredited UDI Organizations
Chapter 20_Medical Device Reporting
Scope
Medical Device Reporting
Chapter 21_Medical Devices-Reports of Corrections and Removals
Scope
Reports of Corrections and Removals
FDA Inspection of Corrections and Removals
Chapter 22_Quality Audit
Scope
Quality Audit
FDA Inspection of Auditing
Appendices
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Appendix F
References and List of FDA Offices
Acronym List
Glossary
Index.