Regulatory Counsel

0910-AI12 202310 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; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests

FDA intends to issue a final 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 identifying special controls for HLA, HPA, and HNA devices that are necessary to provide a reasonable assurance of safety and effectiveness. The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 864 21 U.S.C. 351 21 U.S.C. 360c 21 U.S.C. 371 No NPRM 01/21/2022 87 FR 3250 NPRM Comment Period End 04/21/2022 Final Rule 06/00/2024 No No None No No No Myrna Hanna Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-5739 myrna.hanna@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7219, Silver Spring MD 20993