Chapter 3 - Devices

COMPLIANCE POLICY GUIDE (CPG)

Sub Chapter 300 - General/Processes

Sub Chapter 305 - Anesthesiology (Sub Chptr deleted 8/2000)

Sub Chapter 310 - Cardiovascular

Sub Chapter 315 - Dental

Sub Chapter 320 - Ear, Nose, and Throat

Sub Chapter 325 - Gastoent. and Urology

Sub Chapter 335 - General Hospital

Sub Chapter 345 - Obst. and Gynecology

Sub Chapter 350 - Ophthalmics

Sub Chapter 355 - Orthop. and Phy. Med.

Sub Chapter 370 - Immunology

Sub Chapter 390 - 398 Radiology

Sub Chapter 300 - General/Processes

• Compliance Policy Guide 7124.15
• Revoked-Deletion Page for Compliance Policy Guide Sec. 300.200 Reconditioners/Rebuilders of Medical Devices (Compliance Policy Guide 7124.28)
• Compliance Policy Guide 7124.08
• CPG Sec. 300.400 Contamination of Devices Labeled as Sterile (CPG 7124.01)
• Compliance Policy Guide Sec. 300.500 ,Reprocessing of Single Use, Devices (Compliance Policy Guide 7124.16)
• Compliance Policy Guide 7124.19
• Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (Compliance Policy Guide 7124.30) REVOKED
• CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements (CPG 7124.18)

Sub Chapter 305 - Anesthesiology (Sub Chapter deleted 8/2000)

• Revoked-Deletion Page for Compliance Policy Guide Chapters Sec. 305.100 Acupuncture Devices and Accessories (Compliance Policy Guide 7124.11)

Sub Chapter 310 - Cardiovascular

• Compliance Policy Guide 7124.12
• Compliance Policy Guide 7124.22
• Compliance Policy Guide 7124.23 Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy
• Compliance Policy Guide 7124.07
• Compliance Policy Guide 7124.05

Sub Chapter 315 - Dental

• Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005) (CPG 7124.07)
• Sec. 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

• Compliance Policy Guide 7124.13

Sub Chapter 325 - Gastoent. and Urology

• Compliance Policy Guide 7124.17

Sub Chapter 335 - General Hospital

• CPG Sec. 335.300 Hypnotherapy Devices - Self-Hypnotic Tape Recordings
• Compliance Policy Guide 7124.04
• CPG Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure
• Compliance Policy Guide 7124.20

Sub Chapter 345 - Obst. and Gynecology

• Compliance Policy Guide 7124.21
• Compliance Policy Guide 7124.09
• CPG Sec. 345.300 Menstrual Sponges (CPG 7124.24)

Sub Chapter 350 - Ophthalmics

• Compliance Policy Guide 7124.29

• Chapter 3 - Devices (continued)

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