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HHS/FDA RIN: 0910-AI73 Publication ID: Fall 2023 
Title: Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices  

FDA is issuing a direct final rule and companion proposed rule that would make a minor amendment to 21 CFR part 807 to correct an inconsistency in FDA regulations governing registration and listing requirements that apply to human cells, tissues, or cellular or tissue-based products (HCT/Ps) regulated as devices.  The amendment would make clear that the establishments that manufacture HCT/Ps regulated as devices are required to follow the registration and listing 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  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
Action Date FR Cite
Direct Final Rule  01/00/2024 
Regulatory Flexibility Analysis Required: No  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