Regulatory Counsel

0910-AI73 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices

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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 807 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 No Direct Final Rule 06/00/2023 No None Undetermined No No Karen Fikes Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 karen.fikes@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993