Every Medical Device Is in One of These 3 Categories
A medical device is any piece of equipment that has the intended use of diagnosing, treating or preventing a condition or disease. This means that medical devices can be anything from bandages and thermometers to surgical lasers and pacemakers. That’s an extensive assortment of items!
The U.S. Food and Drug Administration regulates and monitors medical devices closely. If a company wishes to register a device, it must go through an application process based on the device’s complexity and desired usage. There are thousands upon thousands of medical devices, and every one of them falls into one of three classifications. Each class has its own application process and regulatory guidelines. The safety and planned use of the device typically dictates which classification it falls under.
Class I devices are not intended to support or sustain life. They’re usually simple in design and function. They have minimal potential for harm and, therefore, have the least amount of regulation around them. Examples of Class I devices are examination gloves, tongue depressors, bandages and surgical masks.
Most medical devices are classified as Class II devices. Items in this class present a moderate level of risk to the patient and go through more stringent regulatory procedures than Class I devices. Class II devices are used to support the health of a patient but do not sustain life. Examples of Class II devices are electric wheelchairs, infusion pumps and most surgical lasers.
Class III devices directly support or sustain the life of a patient. Items in this class are the most regulated and have the most demanding approval processes. Examples of Class III medical devices are replacement heart valves and implantable pacemakers.
Medical devices span a wide range of applications. Each device class has a job to do in the diagnosis, prevention and treatment of a disease or medical condition. No matter which classification they belong to, medical devices benefit the patients who need them.