Class I and Class II Medical Devices
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. Cogmedix focuses on manufacturing of Class I medical devices and Class II medical devices, each of which have unique standards and requirements.
Class I Medical Devices : General Controls
Class I medical 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 manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. (Most Class I medical devices are exempt from the good manufacturing practices and/or the FDA notification regulations.) These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.
Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Depending on the "stated/purported use" of a device, it may be necessary to obtain a Pre Market Approval (510K) for the device, which is otherwise classifiable as a Class I device. Such devices are referred to as "reserved devices". The electrically powered arthroscope (which is really an endoscope powered electrically) is a case in point. While endoscopes are Class I devices, the electrically powered arthroscopes need PMA (510K) although the manual arthroscopes do not.
Class II Medical Device : General Controls with Special Controls
Class II medical 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. Special controls may include special labeling requirements, mandatory performance standards, and post-market surveillance.
Class II medical devices are held to a higher level of assurance than Class I medical devices in that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles.