Classes of Medical Devices
Published on March 25, 2013
The term medical device can mean anything from a tongue depressor to a pacemaker. Sophisticated medical devices require a very strenuous regulatory procedure, and understanding different classes of medical devices as determined the Food and Drug Administration may help streamline the process.
The FDA classifies medical devices into three different categories: Class I, Class II, and Class III. These classes of medical devices are ranked by potential risk associated to the patient.
Class I Medical Device
Class I medical devices require the least amount of regulatory control. These devices have a long history of safe use and are simple in design. Types of Class I medical devices include tongue depressors, surgical instruments, and gauze.
Class II medical devices require a little more regulatory control to ensure safety and effectiveness. They must comply with special controls set by the FDA, such as special labeling requirements, performance standards, and more. Types of Class II medical devices include heart rate monitors, x-ray systems, and infusion pumps.
Class III medical devices are under the most severe regulatory controls because of their high risk nature. This type of medical device is often used to support or sustain human life and/or can potentially impose unreasonable risk on a patient and require the greatest safety precautions. Types of Class III medical devices include replacement heart valves, pacemakers, and any implantable devices.
Laird Technologies embedded wireless solutions -- Wi-Fi, Bluetooth, and RAMP modules--are designed for use in Class II medical devices. These modules are embedded into devices such as heart rate monitors, infusion pumps, blood pressure monitors, and more. Laird modules are tested and certified for the high reliability and security demanded by healthcare providers.