April 2015—The Clinical and Laboratory Standards Institute has published “Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.” The guide is intended to clarify how to implement the Quality System Regulation, 21 CFR 820, that may be required for some classifications of LDTs.
In developing the guide, the CLSI solicited the help of experts from the in vitro diagnostics industry, as well as representatives from the FDA and Centers for Medicare and Medicaid Services/CLIA, who have many years of experience in complying with FDA regulations and succeeding with FDA inspections. The document translates the FDA-proposed requirements for high-risk LDTs into intuitive, actionable steps to prepare for the change. The guide aims to help users learn where the QSReg differs from current CLIA requirements and how it affects protocols. The document also aids users in finding the tips and hints on methods for complying that have proven to be effective.
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