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HHS/FDA RIN: 0910-AH54 Publication ID: Spring 2018 
Title: Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software  
Abstract:

The Food and Drug Administration is issuing a final rule to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls) and subject to premarket review.  FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness.

 
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: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 864   
Legal Authority: 21 U.S.C 351    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360e    21 U.S.C. 360j    21 U.S.C. 371    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/01/2016  81 FR 10553   
NPRM Comment Period End  05/31/2016 
Final Rule  06/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
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