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HHS/FDA RIN: 0910-AI73 Publication ID: Spring 2022 
Title: ●Amendment to Device Registration and Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products  
Abstract:

FDA intends to issue a direct final rule and companion proposed rule clarifying registration and listing requirements that apply to human cells, tissues,or cellular or tissue-based products regulated as devices to make clear that the establishments that manufacture such products are required to follow the procedures in 21 CFR part 807. This proposed revision to 21 CFR 807 is for consistency with FDA's current regulations under 21 CFR part 1271, subpart A.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 807   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360e    21 U.S.C. 360i    21 U.S.C. 360j    21 U.S.C. 360bbb-8b    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 379k-l    21 U.S.C. 381    21 U.S.C. 393    42 U.S.C. 264    42 U.S.C. 271    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Direct Final Rule  12/00/2022 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: Undetermined 
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