15/16 December 2020
In December 2015 the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) published a Draft Guidance for Industry "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271". This document provides the respective establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations and examples to fulfil the requirements for deviations reporting. The selected examples should represent the most frequently to the CBER reported deviations.
The present guidance does not apply to reproductive HCT/Ps or to HCT/Ps regulated under 21 CFR Part 1270 and recovered before May 25, 2005, to health professionals who implant, transplant, infuse, or transfer HCT/Ps into recipients and to HCT/Ps that are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, nor does it apply to investigational HCT/Ps subject to an investigational new drug (IND) application or an investigational device exemption (IDE).
The documents defined the regulated HCT/Ps with the following criteria:
1. The HCT/P is minimally manipulated;
2. The HCT/P is intended for homologous use only, as reflected by the labelling, advertising, or other indications of the manufacturer’s objective intent;
3. The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; AND
i. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; OR
ii. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function; AND
a) Is for autologous use;
b) Is for allogeneic use in a first-degree or second-degree blood relative; OR
c) Is for reproductive use.
To learn more about the regulated products, the definition of an HCT/p deviation and how to investigate and report, please read the complete draft guidance "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271"