FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Final Guidance Includes Reporting Scenarios for Cell- and Tissue-Based Products

Sept. 12, 2017
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The FDA finalized its 2015 guidance on reporting deviations for human cells, tissues and cellular and tissue-based products, also known as HCT/Ps, offering recommendations for complying with federal reporting requirements and listing the most frequent reports received by CBER.

The guidance applies to products regulated solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 — which cover minimally manipulated products intended only for repair, replacement or supplementation of a recipient’s cells, and produced through a manufacturing process that does not involve combining cells or tissues with another agents.

Manufacturers must investigate and report to the FDA any deviation from regulations related to the core requirements of current good tissue practice within 45 days of discovery — including donor eligibility determinations, screening and testing; equipment, facilities and environmental control; and storage, processing and labeling controls.

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