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 320 - Ear, Nose, and Throat
Sub Chapter 325 - Gastoent. and Urology
Sub Chapter 335 - General Hospital
Sub Chapter 345 - Obst. and Gynecology
Sub Chapter 355 - Orthop. and Phy. Med.
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 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 CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements
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Sub Chapter 310 - Cardiovascular
CPG Sec. 310.100 Pacemaker Reuse CPG Sec. 310.200 Sphygmomanometers - Rx Legend 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
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Sub Chapter 335 - General Hospital
CPG Sec. 335.300 Hypnotherapy Devices - Self-Hypnotic Tape Recordings (PDF - 24KB)CPG Sec. 335.500 Razor Blades, Manicuring Instruments - Not Considered Devices Under 201(h) 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
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