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HHS/FDA RIN: 0910-AI33 Publication ID: Fall 2019 
Title: 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, 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 807    21 CFR 870   
Legal Authority: 21 U.S.C. 301    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   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Karen Fikes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5502, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:301 796-9603