Regulatory Counsel

0910-AH54 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software

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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Fully or Partially Exempt 21 CFR 864 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 ... No NPRM 03/01/2016 81 FR 10553 NPRM Comment Period End 05/31/2016 Final Rule 06/00/2018 No None No No No Jessica Udechukwu Walker Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 jessica.walkerudechukwu@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Silver Spring MD 20993