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Organisational Structure Medical Device Sector

The following is breakdown of the functions and organisation of the Medical Devices Sector. The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.

  • Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturerregistrationwith the FDA, goodmanufacturingtechniques, properbrandingandlabeling, notification of the FDA before marketing the device, and general reporting procedures. Devices in this category include tongue depressors,bedpans, elasticbandages, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment.
  • Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Devices in this class are typicallynon-invasiveand includex-raymachines,PACS, powered wheelchairs,infusion pumps, surgical drapes, surgical needles and suture material,acupunctureneedles.
  • Class III device are those for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Examples of Class III devices which require a premarket approval include replacementheart valves,siliconegel-filled breast implants, implanted cerebral stimulators, implantablepacemakerpulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).

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