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FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search  | ||
Chapter 3 - Devices - Contents FDA/ORA
Compliance Policy Guides
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| 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 | Reprocessing of Single Use 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) |
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| 305.100 | Acupuncture Devices and Accessories (CPG revoked 01/20/2000 FR dated 12/23/1999) | CPG 7124.11 |
Sub Chapter 310 - Cardiovascular |
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| 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 |
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| 315.100 | Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005) | 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 |
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| 320.100 | Ear Piercing Devices | CPG 7124.13 |
Sub Chapter 325 - Gastoent. and Urology |
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| 325.100 | Karaya Gum Powder and Related Devices for Use by Ostomates | CPG 7124.17 |
Sub Chapter 335 - General Hospital |
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| 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 |
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| 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 |
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| 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. |
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| 355.100 | Cellutron Machine (Revoked on 3/10/2005) | CPG 7124.03 |
| 355.200 | Electrical Muscle Stimulators | CPG 7124.26 |
| 355.300 | Ion Generating Devices | CPG 7124.02 |
Sub Chapter 370 - Immunology |
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| 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 |
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| 390.100 | Definition of "Commerce" - 21 CFR 1000.3(d) | 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 Products, Microwave Ovens, and Inherent Class I Laser Products 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) | 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(g)(5) | 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 |
| Updated 07/29/2004 (Chapter comparable to August 2000 edition); 06/20/2002; 07/09/2002; 11/18/2002 tc | ||