دانلود کتاب مقررات سیستم کیفیت برای آزمایشات توسعه یافته در آزمایشگاه

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 On October 3, 2014, the FDA issued draft guidance for regulating LDTs that included notification or registration of LDTs with the FDA, reporting adverse events, and other requirements.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.CLSI solicited the help of experts from the in vitro diagnostics industry in compiling this guide. These experts have many years of experience in complying with FDA regulations and succeeding with FDA inspections.The QSReg can be difficult to understand, so the experts explained each section in plain language. The regulation is compared, where appropriate, to the Clinical Laboratory Improvement Amendments (CLIA) regulations. Similarities and differences are identified. This guide attempts to answer the question: “What does the QSReg require, above and beyond what we already do for CLIA?”Because regulation language can sometimes leave room for interpretation, tips and hints are provided to give the reader ideas about methods for complying that have proven effective. In addition, brief explanations are provided for several terms used in this guide:Class I, II, or III: FDA categorizes laboratory tests by novelty and risk of harm to a patient, should an erroneous result be acted upon. Well-characterized tests with very low risk are typically class l; tests with moderate risk are typically class II; and novel tests with high or unknown risk are typically class III. Manufacture: the process of preparing the LDT for use; eg, measuring and mixing chemicals to make a reagent. Manufacturer: the laboratory that is preparing and using the LDT. Product: the components of the LDT; eg, the reagents.Validation and verification: FDA uses these terms a bit differently from CLIA. For CLIA, manufacturers validate the test and the laboratories verify its performance characteristics before use. For LDTs, the laboratory is the manufacturer, and must validate (prove) that the test is fit for its purpose. The validation may involve conducting studies with patient samples (clinical studies), and comparing the LDT results to patient outcomes or other patient-related parameters. Each new lot of LDT reagent can then be verified to function correctly.