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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medical Device Manufacturers

 

Guide to Inspections of Medical Device Manufacturers 

 

 December 1997 

 

4

 


GUIDE TO INSPECTIONS OF

 

 MEDICAL DEVICE MANUFACTURERS

 

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 

 

Corrective and Preventive Actions  6 

 

Analyzing Quality Problem Information  7 

 

Analyzing Service Records 

 

Control of Nonconforming Product  8 

 

Nonconformity Review and Disposition  8 

 

Change Control  8 

 

Process Validation 

 

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 

 

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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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