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FDA is proposing to classify more than minimally manipulated (MMM) allograft heart valves, an unclassified preamendments device (product code OHA) into class III. FDA believes that there is insufficient information to determine that general controls and special controls provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule after considering 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 and seek the committee's recommendation on classification, 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. The proposed rule would benefit device recipients by reducing the risk of device-related complications and death.