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Inspections, Compliance, Enforcement, and Criminal Investigations
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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
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Sub Chapter 300 - General/Processes
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (CPG 7124.15)
- CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices (CPG 7124.28) Revoked-Deletion 01/04/2000
- CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements (CPG 7124.08)
- CPG Sec. 300.400 Contamination of Devices Labeled as Sterile (CPG 7124.01)
- CPG Sec. 300.500 *Reprocessing of Single Use* Devices (CPG 7124.16)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) 9CPG 7124.19)
- 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) (CPG 7124.30) REVOKED
- CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements (CPG 7124.18)
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Sub Chapter 305 - Anesthesiology (Sub Chapter deleted 8/2000)
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Sub Chapter 310 - Cardiovascular
- CPG Sec. 310.100 Pacemaker Reuse (CPG 7124.12)
- CPG Sec. 310.200 Sphygmomanometers - Rx Legend (CPG 7124.22)
- CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy (CPG 7124.23)
- CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005) (CPG 7124.07)
- Compliance Policy Guide 7124.05
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Sub Chapter 315 - Dental
- CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005) (CPG 7124.07)
- 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) (CPG 7124.05)
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Sub Chapter 325 - Gastoent. and Urology
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Sub Chapter 335 - General Hospital
- CPG Sec. 335.300 Hypnotherapy Devices - Self Hypnotic Tape Recordings (CPG 7124.25)
- CPG Sec. 335.500 Razor Blades, Manicuring Instruments - Not Considered Devices Under 201(h) (CPG 7124.04)
- CPG Sec. 335.700 Surgeon's Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure (CPG 7124.31)
- CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects (CPG 7124.20)
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Sub Chapter 345 - Obst. and Gynecology
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Sub Chapter 350 - Ophthalmics
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