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Compliance Program
Manual for FDA Staff

ATTACHMENT B-1

"HIGH RISK DEVICES" *

ANESTHESIOLOGY

Gas machines for analgesia.

CARDIOVASCULAR

Artificial heart, permanent implant and short term use.

Coronary artery retroperfusion system.

Laser coronary angioplasty device.

Percutaneous conduction tissue ablation electrode.

DENTAL

Total temporomandibular joint (TMJ) prosthesis.

TMJ implants.

Glenoid fossa prosthesis.

Mandibular condyle prosthesis.

Interarticular disc prosthesis.

Collagen for any dental use.

Bone filling and augmentation materials.

Absorbable materials.

Subperiosteal implants.

EAR, NOSE AND THROAT

Total ossicular prosthesis replacement.

GASTROENTEROLOGY AND UROLOGY

Endoscope and/or accessories.

Extracorporeal hyperthermia system.

Extracorporeal photophersis system.

Extracorporeal shock-wave lithotriptor.

Mechanical/hydraulic incontinence devices.

 

*High Risk Devices are Class III and Class II devices that are life-sustaining/life-supporting devices (based on the Advisory List of Critical Devices – Federal Register, March 17, 1988) or significant risk devices, as defined by 21 CFR 812.3(m) for Investigational Devices Exemptions.

 

 

 

GENERAL MEDICAL USE

Catheters: Cardiology - diagnostic and treatment types.

Gastroenterology and urology - biliary and urologic.

General hospital - long-term percutaneous, implanted,

subcutaneous and intravascular.

Collagen implant material for use in orthopedics and plastic surgery.

Lasers for use in Ob/Gyn, cardiology, gastroenterology, urology, pulmonary, ophthalmology and neurology. Tissue adhesives for use in neurology, gastroenterology, ophthalmology, general and plastic surgery, and cardiology.

GENERAL AND PLASTIC SURGERY

Absorbable hemostatic agents.

Artificial skin.

Injectable silicone.

Silicon gel filled angelchik reflux valve.

Silicon gel filled chin prosthesis.

OBSTETRICS AND GYNECOLOGY

Cervical dilator.

Chorionic villus sampling catheter, phase II (pregnancy continued to term).

Contraceptive devices: cervical cap, diaphragm, and sponge.

Silicone gel filled testicular prosthesis.

OPHTHALMICS

Extended wear contact lens.

Retinal reattachment systems: sulfur hexafluoride, silicone oil, tacks, perfluropropane.

ORTHOPEDICS

Implantable ligament prostheses.

Bone growth stimulator.

Calcium tri-phosphate/hydroxyapatite ceramics.

Xenografts

RADIOLOGY

Hyperthermia systems and applicators.

SUPPLEMENTAL INFORMATION

 

  • With regard to portable oxygen generators, the molecular sieve, or oxygen concentrator device, is not considered a critical device for purposes of applying the QS/GMP, when it is intended for home respiratory therapy use.