In late December, FDA released a 16-page draft guidance on deviation reporting for non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361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 Title 21 of the Code of Federal Regulations (CFR) Part 1271. The guidance describes scenarios to illustrate who must report, what must be reported, and when such reports must be submitted to FDA. Also provided are examples of both reportable and non-reportable events, including examples chosen to illustrate the most frequently reported HCT/P deviations that have historically been submitted to FDA’s Center for Biologics Evaluation and Research (CBER). The deviation examples are divided into five categories: ● donor eligibility ● donor screening ● donor testing ● processing and process controls, and ● receipt, pre-distribution, shipment, and distribution.
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