The distinguishing factor between whether a device can be designated as a Class I, Class II, or Class III device is based on the safety and risk posed to the patient using the device. Class I devices are low risks and require general controls. A Class II device presents a higher risk and requires general and special controls. A Class III device is high risk or has no equivalency. General controls apply to all classes of devices.
What exactly are “general” controls and “special” controls, as defined by the FDA?
- All devices require general controls and require 510K, or pre-market notification, unless exempted.
- All devices must be manufactured under Quality System Regulations, also known as Good Manufacturing Practices (GMP), which assure that devices are manufactured in an environment of controlled processes that produces a consistent quality end product.
- All devices must be properly labeled; intended use indicated on the labeling must be the wording cleared by the FDA.
- Manufacturers must have an establishment registration and list their devices with the FDA. This enables FDA to know where and what type of device is manufactured for future inspections and quality audits.
- Adverse events must be reported through the Medical Device Reporting program (MDR). This reporting process applies to all manufacturers, user facilities, and importers.
Class II and III medical devices require special controls. The table below lists examples of special controls.
In summary, general controls will apply to all devices while special controls are more specific and may be devised to introduce controls needed for situations introduced by certain devices. More information on this topic is available on the FDA website: http://www.fda.gov/Training/CDRHLearn/ucm281656.htm.