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HHS/FDA

RIN: 0910-AI73

Publication ID: Spring 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
Abstract: FDA intends to issue 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

Timetable:

Action	Date	FR Cite
Direct Final Rule	06/00/2023

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 Email: karen.fikes@fda.hhs.gov