Class I refers to a category of medical devices that are considered to have the lowest risk to patients. These devices are typically simple in design and are subject to the least regulatory control. Examples of Class I devices include items like bandages, tongue depressors, and handheld surgical instruments. Manufacturers of Class I devices must adhere to general controls set by regulatory bodies, such as the U.S. Food and Drug Administration (FDA). These controls ensure that the devices are safe and effective for their intended use, although they do not require premarket approval like higher-risk classes.