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HHS/FDA RIN: 0910-AI12 Publication ID: Fall 2022 
Title: Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 864   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 360c    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/21/2022  87 FR 3250   
NPRM Comment Period End  04/21/2022 
Final Rule  07/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
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
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: karen.fikes@fda.hhs.gov