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CPGM 7382_845 TOPIC

COMPLIANCE PROGRAM PART NUMBER AND PAGE LOCATION

 

CS

I

II

III

IV

V

VI

 ATTACHMENT
Administrative/Regulatory Action (Enforcement Action) 1 1 1 3–7, 10, 12-14   1-13 1, 3, 9-10, 12-13 C 1-9, G 3
Analytical         1-3      
Attachment Titles             7  
Audits      

 

 4   12   C 1, 3-4
Case Experts (Case Officers)           8, 10 12  
Class I Devices     3-6 11-12   5, 12 7 A 1-14
  • Class I Exempt Devices
    5-6 11     7 A 1-14
Class II/III Devices     3-5 11-12   5, 12   B 8, 11

C 2, 4
Complaints (Complaint Files)   2 5-6 5, 8       C 1, 3

E 3-4, 6
COMSTAT 2   2 11     2, 8  
Concurrence & Consulting Required       9, 14   5, 8    
Consultant  

 

 6-7 C 4, 6-7
Contacts (Inform)

 

     6 9, 12-13 1 8, 10 7-14  
Contracting Firms   1            
Corrections and Removals (CAR) 1-3 1, 3 1 1, 4 -5   12 1,7 G 1-3
Design Control (see Subsystems: Design Controls)                
Distributor

 

   2-3 1     8   E 1,

F 1-3

G 2
Electro-Optical Specialists     6          
Electronic Records and Electronic Signatures       5-6   5 1, 11, 13  
Exports       7, 11-12   13   C 8-9
FDA Modernization Act   2         13  
Field Accomplishments and Compliance Tracking System (FACTS) 1-2   4 11, 14   5 9, 12-13  
Food, Drug & Cosmetic Act (FD&C Act or the Act)       8, 10-11   2, 4, 7- 9 1 C 1-5, 8
Guide to Inspections of Quality Systems (QSIT Guide)   1-2 2-6 1-5, 7-9, 11-13   1-2, 5-6 1, 13  
High Risk Devices/Significant Risk Devices     3, 5-6     1 2, 7 B 1-18

B-1 1-3
Implantable and Life Sustaining Devices       10       B 1-18
Importer or Imports 1-3 1 11-12 F 1

G 1-3
In Vitro Diagnostic Devices (IVDs)   2     1   1-2  
Inspectional Observations Form FDA-483 1   6 4 -5, 9, 12-14   2-3, 8,

10-12

   C 2, 4, 8-9
Inspection Priorities     3-6 4-6        
Inspectional Procedures 2-3     4 -14   3-8    
Inspectional Strategy (also known as Quality System Inspection Technique [QSIT]) 1-3 1-2 2-6 1-14   7    
INSPECTION TYPES:

Abbreviated EI

  

1

    

3

  

1-2, 6

        
Baseline (Comprehensive) EI 1   3, 5 1-2        
Follow-up EI 1   3-4, 6 1, 3, 7   2, 4 -7   C 5
For Cause EI 1, 3 2 5 7-8        
Foreign EI       7        
Initial EI     5          
Level 1 1-3   3, 5 2, 4, 6   2    
Level 2 1-3   3, 4, 5 2, 4, 5   2    
Level 3 1-3   3, 6 2 -3   2, 5 - 6    
Pre-Approval EI     2          
Routine EI     5          
Medical Device Reporting (MDR)

 

 1-3 1-2 1, 4 - 6 1, 4-6, 13   5, 11-12 3, 7, 9-10,13 C 1-4

E 1-9

G 1
Medical Device Tracking 1-3 1, 3 1 1, 4-6, 13   5, 12 1, 7, 13 F 1-3
OC Organizational Chart           10 14  
Packaging (seal)       6 2-3 3 5-6  
Post-Inspectional Notification Letter 1   6 11   9   C 8-9
Premarket Notification 510(k)     4 8, 14       B 8

C 4, 6, 8-9

D 1
Premarket Approval (PMA)     4 8   9   B 6, 9-10

C 4, 6, 8-9

D 1
Pre-Notification     6          
Product Assignment Codes (PAC) 1, 3   5-6 1, 5, 7, 9, 10, 12        
Profile Classes     4 11        
Profile Data Sheet     4 11   5, 7    
Quality Assurance (QA)     6 8   3, 6   C 1-4

F 3
Quality System Regulation or Requirements 2-3 1-2 1, 5-6 1-6,

10-13

   1-9 1,10 B 2

C 1-9
Radiation Emitting Device       10   13 1, 13  
Recalls   3 4 8   4-8, 12 1 G 2, 4
References (Publications)             1-7 G 2-3
Registration and Listing 2 1, 3 1 1, 5, 7,

13 - 14

   12 13  
Remarketed Devices       12-13        
Repacker/Relabeler     3-4 12   8    
Reporting Requirements & Info.

 

 1-3 2 6 12-13   3-11   E 1-9

F 1-3

G 1-3
Samples       6-7, 10-11 1-3 2-3, 10-12    
Sampling Records       12   2-3    
Situation I       3, 12   1-2, 6-7, 10, 13    
Situation II           2    
Specification Developers     3-4          
Sterilization/sterility 1-3 1 2, 4, 6 5-10 1-3 3-4 3-7, 11, 13 B 17
SUBSYSTEMS:

Corrective and Preventive

Actions (CAPA)

  1-2 4 1-8, 11   1    
Design Controls 2 1 2 1-4, 8-9   6 2-3, 7 D 1
  • Design Control Records
       8     7 D 1
Production and Process

Controls (P&PC)

 3 1   1-2, 4 -5, 9        
Management Controls   1   1-4   1    
Facilities and Equipment

Controls

   1   1        
Materials Controls   1   1        
Documents/Records/Change

Controls

   1   1        
Surgical Implant or Sustaining Life Devices   3 5 10     7 B 1-18

B-1 1

E 6
Tracking (see Medical Device Tracking)                
Web Sites     2-3 5-6, 13-14   1, 3 2-3, 9,

12-13

 E 7, 9

F 2
Warning Letters 1, 2   6 3, 5, 6   1, 4-8,

11-13

 7 C 1-5, 9
  • Model Warning Letters
           5-6 7 C 1-3