FDA 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
标准简介
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[附网盘链接]是于过去发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为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[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
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 Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION We, the Food and Drug Administration (FDA), are issuing this guidance to provide you, establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-
based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations under Title 21 of the Code of Federal Regulations (CFR) Part 1271, with recommendations and relevant examples for complying with the requirements under 21 CFR 1271.350(b) to investigate and report HCT/P deviations. The examples provided in this guidance have been chosen to illustrate those HCT/P deviations that have been most frequently 1
reported to FDA’s Center for Biologics Evaluation and Research (CBER). 2
This guidance document does not apply to reproductive HCT/Ps or to HCT/Ps regulated under 21 CFR Part 1270 and recovered before May 25, 2005. Furthermore, this guidance does not apply to healthcare professionals who implant, transplant, infuse, or transfer HCT/Ps into 3
recipients. 1
See FDA’s Annual Report Summaries at https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm
129757.htm. 2
See 21 CFR 1271.150(c)(3)). 3
See 21 CFR 1271.15(d). However, FDA notes that healthcare professionals have an important role in identifying HCT/P deviations and reporting HCT/P deviations to manufacturers of HCT/Ps. Further, manufacturers may seek to obtain additional information from healthcare professionals such as recipient culture reports or recipient clinical records when investigating the possible transmission of communicable disease related to HCT/Ps that the manufacturer made available for distribution.
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