Regulatory Counsel

0910-AI12 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Immunology and Microbiology 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 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 Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 864 21 U.S.C. 351 21 U.S.C. 360(c) 21 U.S.C. 371 No NPRM 09/00/2021 No No None No No No Karen Fikes Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 karen.fikes@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993