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FDA is proposing to classify more than minimally manipulated (MMM) allograft heart valves, an unclassified preamendment device (product code OHA) into class III, which requires the filing of a premarket approval (PMA) application. FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule based on the recommendations of the Circulatory System Devices Panel, regarding the classification of MMM allograft heart valves. These devices are currently reviewed through the 510(k) process. As part of the classification process, we are required to discuss the potential classification before an advisory committee, which took place in October 2014. The proposed rule would provide necessary clarity and transparency regarding the regulatory controls required to ensure that these devices are reasonably safe and effective. FDA expects the proposed rule to have a one-time cost of reclassification for currently marketed devices and a one-time cost of PMA preparation and submission for manufacturers of new devices. Both current and future manufacturers would face recurring costs of PMA annual reporting. FDA would also face costs from reviewing PMA submissions and annual reports. The proposed rule would benefit device recipients by reducing the risk of device-related complications and death.