December 1997 

4

TABLE OF CONTENTS 

INTRODUCTION  1 

GENERAL  2 

PRE-INSPECTIONAL ACTIVITY  2 

GMP INSPECTIONAL STRATEGY  3 

Preannouncements, 483 Annotations, Post Inspectional Correspondence  3 

DIRECTED DEVICE INSPECTION  3 

Complaint Handling System  4 

Complaint Handling Procedures  5 

Determining Whether An Investigation Is Necessary  5 

MDR Regulations - 21 CFR 803  6 

Servicing  6 

MDR-Reportable Service Reports  6 

Corrective and Preventive Actions  6 

Analyzing Quality Problem Information  7 

Analyzing Service Records  7 

Control of Nonconforming Product  8 

Nonconformity Review and Disposition  8 

Change Control  8 

Process Validation  9 

Components  11 

Quality Audits  11 

Design Controls  12 

PMA Devices  13 

Medical Device Tracking  13 

COMPREHENSIVE DEVICE INSPECTION  13 

General Provisions  13 

Quality System Requirements  14 

Personnel  15 

Document Controls  15 

Purchasing Controls  15 

Identification and Traceability  16 

Production and Process Controls  17 

Production and Process Specifications  17 

Reworking  17 

Buildings  17 

Environmental Control  17 

Contamination Control  18 

Personnel  18 

Equipment  18 

Inspection, measuring, and test equipment  19 

Acceptance Activities  19 

Labeling and Packaging Control  20 

Handling, Storage, Distribution, and Installation  20 

Records  21 

Device master record  21 

Device history record  21 

Quality System Record  22 

PRE-APPROVAL DEVICE INSPECTION  22 

STERILE DEVICES  22 

THE SMALL MANUFACTURER  23 

WRITTEN PROCEDURES - "ESTABLISH"  23 

ATTACHMENTS 

A - Medical Device Industry Initiative  25 
B - Temporary Enforcement Moratorium  29 
C - FOI and Design Controls  31