Chapter 3 - Devices

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

• CPG Sec. 300.100 Inspection of Manufacturers of Device Components
• CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices - Revoked-Deletion 01/04/2000
• CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements
• CPG Sec. 300.400 Contamination of Devices Labeled as Sterile
• CPG Sec. 300.500 *Reprocessing of Single Use* Devices
• CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))
• CPG Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) REVOKED

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

• CPG Sec. 305.100 - Acupuncture Devices and Accessories - Revoked-Deletion 01/24/2000

Sub Chapter 310 - Cardiovascular

• CPG Sec. 310.100 Pacemaker Reuse
• CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy
• CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)
• CPG Sec. 315.200 Status of Dental Supplies such as Denture Cleaners, Adhesives, Cushions, and Repair Materials as a Device or Cosmetic - revoked 8/7/02

Sub Chapter 315 - Dental

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

Sub Chapter 320 - Ear, Nose, and Throat

• CPG Sec. 320.100 Ear Piercing Devices

Sub Chapter 325 - Gastoent. and Urology

• CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates

Sub Chapter 335 - General Hospital

• CPG Sec. 335.300 Hypnotherapy Devices - Self-Hypnotic Tape Recordings
• CPG Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure (PDF - 17KB)
• CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects

Sub Chapter 345 - Obst. and Gynecology

• CPG Sec. 345.100 Condoms; Defects - Criteria for Direct Reference Seizure
• CPG Sec. 345.200 Diaphragms - Rx Devices
• CPG Sec. 345.300 Menstrual Sponges

Sub Chapter 350 - Ophthalmics

• CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets

 

• Chapter 3 - Devices (continued)