0910-AI33 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Cardiovascular Devices; Classification of More Than Minimally Manipulated Allograft Heart Valves

FDA is proposing to classify more than minimally manipulated (MMM) allograft heart valves (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 is intended to benefit device recipients by reducing the risk of device-related complications and death.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 807 21 CFR 870 21 U.S.C. 351 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360j 21 U.S.C. 360l 21 U.S.C. 371 No NPRM 11/00/2023 No No None Undetermined No No No Ana Loloei Policy Advisor 0910 Food and Drug Administration FDA 301 796-8774 anahita.loloeimarsal@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5504, Silver Spring MD 20993