Chapter 3 - Devices - Contents FDA/ORA
Compliance Policy Guides
Chapter 3 - Devices
Contents
Sub Chapter 300 - General/Processes
|
| 300.100 |
Inspection of Manufacturers of Device Components |
CPG 7124.15 |
| 300.200 |
Reconditioners/Rebuilders of Medical Devices (Revoked
01/04/1999) |
CPG 7124.28 |
| 300.300 |
Ineffective Devices-502(f)(l) Labeling
Requirements |
CPG 7124.08 |
| 300.400 |
Contamination of Devices Labeled as Sterile |
CPG 7124.01 |
| 300.500 |
Reuse of Medical Disposable Devices |
CPG 7124.16 |
| 300.600 |
Commercial Distribution with Regard to Premarket
Notification (Section 510(k)) |
CPG 7124.19 |
| 300.700 |
Direct Reference Authority for Class III Medical
Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval
Application (PMA) (Revoked 10/07/2002) |
CPG 7124.30 |
| 300.750 |
Class III Devices Subject to 515(b) Requirements |
CPG 7124.18 |
|
| Sub Chapter 305 -
Anesthesiology (Sub Chptr deleted 8/2000)
|
| 305.100 |
Acupuncture Devices and Accessories (CPG
revoked 01/20/2000 FR dated 12/23/1999) |
CPG 7124.11 |
|
| Sub Chapter 310 - Cardiovascular
|
| 310.100 |
Pacemaker Reuse |
CPG 7124.12 |
| 310.200 |
Sphygmomanometers - Rx Legend |
CPG 7124.22 |
| 310.210 |
Blood Pressure Measurement Devices
(Sphygmomanometers)- Accuracy |
CPG 7124.23 |
|
| Sub Chapter 315 - Dental
|
| 315.100 |
Dentures; Sale in Interstate Commerce of Dentures
by Persons not Licensed to Practice Dentistry |
CPG 7124.07 |
| 315.200 |
Status of Dental Supplies Such as Denture
Cleaners Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG
REVOKED effective 8/07/2002) |
CPG 7124.05 |
|
| Sub Chapter 320 - Ear, Nose, and
Throat
|
| 320.100 |
Ear Piercing Devices |
CPG 7124.13 |
|
| Sub Chapter 325 - Gastoent. and
Urology
|
| 325.100 |
Karaya Gum Powder and Related Devices for Use by
Ostomates |
CPG 7124.17 |
|
| Sub Chapter 335 - General
Hospital
|
| 335.300 |
Hypnotherapy Devices - Self Hypnotic Tape
Recordings |
CPG 7124.25 |
| 335.500 |
Razor Blades, Manicuring Instruments - Not
Considered Devices Under 201(h) |
CPG 7124.04 |
| 335.700 |
Surgeon's Gloves and Patient Examination Gloves;
Defects - Criteria for Direct Reference Seizure |
CPG 7124.31 |
| 335.800 |
Clinical Thermometer - Adulteration; Misbranding
Defects |
CPG 7124.20 |
|
| Sub Chapter 345 - Obst. and
Gynecology
|
| 345.100 |
Condoms; Defects - Criteria for Direct Reference
Seizure |
CPG 7124.21 |
| 345.200 |
Diaphragms - Rx Devices |
CPG 7124.09 |
| 345.300 |
Menstrual Sponges |
CPG 7124.24 |
|
| Sub Chapter 350 - Ophthalmics
|
| 350.100 |
Packaging Technologies and Tamper-Resistant
Packaging Requirements for Contact Lens Solutions and Tablets |
CPG 7124.29 |
|
| Sub Chapter 355 - Orthop. and
Phy. Med.
|
| 355.100 |
Cellutron Machine |
CPG 7124.03 |
| 355.200 |
Electrical Muscle Stimulators |
CPG 7124.26 |
| 355.300 |
Ion Generating Devices |
CPG 7124.02 |
|
| Sub Chapter 370 - Immunology
|
| 370.100 |
Cytotoxic Testing for Allergic Diseases |
CPG 7124.27 |
| 370.200 |
RIA Analysis of Hair to Detect the
Presence of Drugs of Abuse (Revoked effective 01/05/2004) |
CPG 7124.06 |
|
| Sub Chapter 390 - 398 Radiology
|
| 390.100 |
Definition of "Commerce" - 21 CFR
1000.3(g) |
CPG 7133.02 |
| 390.200 |
Determination by Secretary that Product Fails to
Comply or has Defect - 21 CFR 1003.11 |
CPG 7133.05 |
| 390.225 |
Early Defects or Noncompliance - 21 CFR 1004.6 |
CPG 7133.06 |
| 390.300 |
Assessment of Civil Penalties Against
Manufacturers and Importers of Electronic Products |
CPG 7133.23 |
| 390.400 |
Examples of Electronic Products Subject to the
Reporting Requirements Under 21 CFR 1000.15(a) |
CPG 7133.01 |
| 390.425 |
Records and Reports; Applicability - 21 CFR
1002.1 |
CPG 7133.07 |
| 390.500 |
Definition of "High-Voltage Vacuum
Switch" - 21 CFR 1002.61(a)(3) and (b)(2) |
CPG 7133.04 |
| 391.100 |
Advertisement Literature for High-Intensity
Mercury Vapor Discharge Lamps (Revoked effective 06/20/2002) |
CPG 7133.13 |
| 391.200 |
Warning Statement in Advertisements for
High-Intensity Mercury Vapor Discharge Lamps That Are Not Self- Extinguishing (21
CFR 1040.30(e)(3)) |
CPG 7133.15 |
| 393.100 |
Enforcement Policy for Certain Laser Light Shows,
Displays, and/or Devices. (21 CFR 1040.10 and 1040.11) |
CPG 7133.10 |
| 393.200 |
Laser(s) as Medical Devices for Facelift, Wrinkle
Removal, Acupuncture, Auricular Stimulation, etc. |
CPG 7133.21 |
| 394.100 |
Retention of Microwave Oven Test Records |
CPG 7133.19 |
| 394.500 |
Importation of Television Receivers and
MicrowaveOvens for Investigation and Evaluation |
CPG 7133.22 |
| 396.100 |
Applicability of the Sunlamp Performance Standard
To UVA Tanning Products (Revoked effective 6/20/2002) |
CPG 7133.16 |
| 396.200 |
Exemption for Certain Sunlamp Product Purchaser
Records |
CPG 7133.18 |
| 396.300 |
Defective Suntanning Booths and Bed |
CPG 7133.24 |
| 396.400 |
Policy on Warned on Sunlamp Products |
CPG 7133.29 |
| 397.100 |
Accuracy Requirements for Indication of
Temporal-Maximum Ultrasonic Power, 21 CFR 1050.10(c)(1)(ii) |
CPG 7133.14 |
| 398.100 |
Definition of General Purpose Radiographic X-Ray
System - 21 CFR 1020.30(b)(17) |
CPG 7133.11 |
| 398.200 |
Hazardous Diagnostic X-ray Systems |
CPG 7133.25 |
| 398.300 |
Registration of Assemblers of Diagnostic
X-Ray Systems as Device Manufacturers |
CPG 7124.14 |
| 398.325 |
Regulatory Actions Against Assemblers
Noncompliant Diagnostic X-Ray Equipment |
CPG 7133.12 |
| 398.350 |
Regulatory Actions Against Assemblers of X-ray
Equipment that Fail to File Reports of Assembly |
CPG 7133.28 |
| 398.375 |
Obligations of Factory-based Manufacturers and
Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for
Diagnostic X-ray Equipment |
CPG 7133.27 |
| 398.400 |
Automatic Adjustment of the X-ray Field Size to
the Selected Spot-Film Size - 21 CFR 1020.31(g)(1) |
CPG 7133.09 |
| 398.425 |
Override of Positive Beam Limitation - 21 CFR
1020.31(e)(2)(v) |
CPG 7133.08 |
| 398.450 |
Applicability of Positive Beam Limitation (PBL)
Requirements When PBL is Provided on "Other than Stationary General
Purpose" Radiographic System |
CPG 7133.26 |
| 398.475 |
Minimum X-ray Field Size for Spot-Film Operation
of Fluoroscopic Systems with Fixed SID and Without Stepless Adjustment of the Field
Size
(Revoked 11/12/2002) |
CPG 7133.17 |
| 398.600 |
Certification and Identification of X-ray
Components - Sections 1010.2 and 1020.30(e) |
CPG 7133.03 |
| 398.700 |
Reloaders of X-ray Tube Housing Assemblies;
Applicability of Medical Device Establishment Registration, Device Listing and
Biennial Inspection |
CPG 7133.20 |
|
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| Updated 12/28/2000 (Chapter
comparable to August 2000 edition); 06/20/2002; 07/09/2002; 11/18/2002 |
