What risk level classification requires the most rigorous Premarket Approval (PMA) for medical devices?
Answer
Class III
Medical devices are stratified into three primary risk classes, with Class III representing the highest level of hazard potential. Class III devices are those deemed life-sustaining, life-supporting, or potentially injurious if they fail or cause harm. Consequently, these devices must undergo the most stringent regulatory pathway, known as Premarket Approval (PMA). This process demands substantial scientific data and evidence, closely mirroring the requirements for new drug approval, to assure the FDA that the device is safe and effective for its intended use, such as in the case of an implantable pacemaker or a new artificial hip joint.
Related Questions
Which FDA center oversees new drug review for safety and effectiveness?What food categories does the USDA/FSIS primarily regulate, separating them from FDA oversight?What is the key pre-market approval difference between a new drug and a supplement?What risk level classification requires the most rigorous Premarket Approval (PMA) for medical devices?What official daily publication houses proposed rules and notices from agencies like the FDA?Approximately what percentage of the U.S. food supply falls under the FDA's regulatory jurisdiction?What requirement applies to cosmetics regarding market entry, unlike prescription drugs?What strategic focus did the Food Safety Modernization Act (FSMA) establish for food processing facilities?Under which U.S. federal department does the Food and Drug Administration (FDA) operate?Which act granted the FDA authority to regulate the manufacture and marketing of tobacco products?