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 |
37, 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 |
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
|
|
5-6 |
7 |
C 1-3 |