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CLSI QSRLDT Ed2
Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.
This practical guide is intended for the laboratory that is creating laboratory-developed tests (LDTs) that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part 820. LDTs are those in vitro diagnostic devices that are intended for clinical use and are designed, manufactured, and used within a single laboratory. This practical guide is intended to clarify how to implement the QSReg that may be required for some classifications of LDTs. On October 3, 2014, the FDA issued draft guidance for regulating LDTs that included notification or registration of LDTs with the FDA, reporting adverse events, and other requirements. This document only addresses the QSReg that is currently applicable to manufacturers and is expected to become applicable for some classifications. On May 6, 2024, the FDA published a final rule establishing LDTs as devices under the Federal Food, Drug, and Cosmetic Act.
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Clinical And Laboratory Standards Institute [clsi]