REGULATORY UPDATE: FDA Issues HCT/P Small Entity Compliance Guide

November 01, 2022

The Food and Drug Administration recently announced the availability of a final guidance, Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Small Entity Compliance Guide. This level 2 guidance, issued in a question-and-answer format, is for immediate implementation. The agency intends for the guidance to help small entity establishments that manufacture HCT/Ps to better understand the comprehensive framework for HCT/Ps set forth in 21 CFR 1271. This guidance supersedes the guidance of the same title dated August 2007.

The compliance guide reflects the amendments of part 1271 based on the following: the final rule published in the Federal Register of June 22, 2016 (81 FR 40512), which amended certain regulations regarding donor eligibility, including the screening and testing of donors of particular HCT/Ps; and the final rule published in the Federal Register of Aug. 31, 2016 (81 FR 60170), which amended the regulations governing drug establishment registration and drug listing and included amendments to certain establishment registration and listing regulations for HCT/Ps.

FDA is accepting comments on the final guidance at any time. Submission instructions are available in the Federal Register notice.