FDA Finalizes Guidance on Deviation Reporting for HCT/Ps
Posted 06 September 2017 | By
The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations.
The 20-page guidance, first drafted in December 2015, includes additional examples and editorial changes to improve clarity from the draft.
FDA says the examples - which deal with donor eligibility, screening, testing and processing and process controls – are intended to illustrate deviations that have been most frequently reported to FDA and its Center for Biologics Evaluation and Research (CBER).
Any establishment that manufactures non-reproductive HCT/Ps that meet certain criteria from the guidance must investigate all HCT/P deviations related to a distributed HCT/P for which the establishment performed a manufacturing step and report them to FDA within 45 days of the discovery of the event.
"If the HCT/P deviation occurred in a facility that performed a manufacturing step for you under contract, agreement, or other arrangement, the time period for reporting will start when that contract establishment learned about the event," FDA says.
The release of the final guidance comes as FDA has said recently it plans to issue a new stem cell therapy regulatory framework later this fall.
FDA Commissioner Scott Gottlieb said in a statement Wednesday: "Today’s policy action is another step forward in our development of a comprehensive framework for regulating cell and tissue products, one that provides clear rules and balances patient protection with the need for efficient oversight of these technologies."
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