Regulations

FDA Device Classifications

The Food and Drug Administration has developed a three-tiered classification of medical devices which is based on the level of control required to assure the safety and effectiveness of the device. These classification procedures are described in the Code of Federal Regulations, Title 21, part 820, which is commonly referred to simply as 21 CFR 820.

Class I: General Controls

Class I devices are only subject to general controls, and present minimal potential for harm to the user. Often they’re less complex in design than Class II or Class III devices, and are generally exempt from the good manufacturing practices (GMP) and/or the FDA notification regulations. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques (GMT), proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures. These controls are considered 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 use. Devices in this category would include such devices as tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments, wheelchairs, and other similar types of equipment.

Depending on the "stated use" of a device it may also be necessary to obtain either a 510K (Pre-market Notification) or Pre-market Approval (PMA) for the device, which is otherwise classifiable as a Class I device. These devices are referred to as "reserved devices”. For example, an electrically powered arthroscope, which is really just a common endoscope being powered electrically, is a case in point. While endoscopes are Class I devices and usually do not require a PMA, an electrically powered arthroscope would require a PMA (510k).

Class II: General Controls with Special Controls

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. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in Class II are held to a higher level of assurance than Class I devices and 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 such devices as x-ray machines, electrically powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles.

Class III: General Controls and Premarket Approval

A Class III device is one 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. In addition to the general controls of Class I, such a device needs Premarket Approval (PMA) and a scientific review to ensure the device's safety and effectiveness. Class III devices are described as those for which "…insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."

Examples of Class III devices which require a Premarket Approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and other life-supporting devices.