Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Device Manufacturers
Guide to Inspections of Medical Device Manufacturers
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December 1997
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4
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GUIDE TO INSPECTIONS OF
MEDICAL DEVICE MANUFACTURERS
TABLE OF CONTENTS
GENERAL 2
Preannouncements, 483 Annotations, Post Inspectional Correspondence 3
Complaint Handling Procedures 5
Determining Whether An Investigation Is Necessary 5
MDR Regulations - 21 CFR 803 6
MDR-Reportable Service Reports 6
Corrective and Preventive Actions 6
Analyzing Quality Problem Information 7
Control of Nonconforming Product 8
Nonconformity Review and Disposition 8
Components 11
PMA Devices 13
COMPREHENSIVE DEVICE INSPECTION 13
Quality System Requirements 14
Personnel 15
Identification and Traceability 16
Production and Process Controls 17
Production and Process Specifications 17
Reworking 17
Buildings 17
Personnel 18
Equipment 18
Inspection, measuring, and test equipment 19
Labeling and Packaging Control 20
Handling, Storage, Distribution, and Installation 20
Records 21
PRE-APPROVAL DEVICE INSPECTION 22
WRITTEN PROCEDURES - "ESTABLISH" 23
ATTACHMENTS
A - Medical Device Industry Initiative 25
B - Temporary Enforcement Moratorium 29
C - FOI and Design Controls 31
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Note: this document is reference materials for investigators and other FDA personnel. This Document does not bind FDA, and does not confer any rights, privileges, benifits, or immunities for or on any personnel.
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