Regulatory Counsel

0910-AI12 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Hematology and Pathology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen or Antibody Tests

FDA intends to issue a proposed rule to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices as a group of devices with each device having its own product code. FDA is proposing to classify HLA, HPA, and HNA devices into class II (special controls). FDA is also proposing to identify special controls for HLA, HPA, and HNA devices that are necessary to provide a reasonable assurance of safety and effectiveness. The proposed rule would include the recommendations of the Blood Products Advisory Committee regarding the classification of these devices.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No Regulatory 21 CFR 864 21 U.S.C. 351 21 U.S.C. 360 21 U.S.C. 371 No NPRM 06/00/2019 No No None No No No Jessica Udechukwu Walker Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 jessica.walkerudechukwu@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Silver Spring MD 20993