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HHS/FDA RIN: 0910-AI12 Publication ID: Spring 2019 
Title: Medical Devices; Hematology and Pathology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen or Antibody Tests 
Abstract:

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.

 
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: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 864   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2019 
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:
Jessica Walker Udechukwu
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71,
Silver Spring, MD 20993
Phone:240 402-7911
Email: jessica.walkerudechukwu@fda.hhs.gov