The FDA categorizes medical devices into three classes.8 Class I medical devices pose minimal risk of injury or harm to patients and/or users. General regulatory controls, i.e., registering the device, proper branding and labeling, and proper manufacturing techniques assure their safety and effectiveness. Examples of Class I medical devices include tongue depressors, some dental instruments, dental floss, isolation gowns, examination and surgical gloves, and eye protection.
Class II medical devices are those for which general regulatory controls alone cannot assure safety and effectiveness. These devices are subject to special labeling requirements, mandatory performance standards, pre-marketing FDA notification, and post-marketing surveillance. Examples of Class II medical devices include X-ray machines, infusion pumps, surgical needles, surgical drapes, surgical gowns, surgical masks, and particulate respirators.
Class III medical devices pose the greatest risk of injury or harm to patients and/or users and their safety and effectiveness cannot be assured solely through general or special regulatory controls. They must undergo scientific review by an expert panel and must obtain pre-marketing approval from the FDA. Examples of Class III medical devices include implantable pacemakers, heart valves, automated external defibrillators, and endosseous implants (e.g., dental implants).
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