CLSI Publishes New Guide for Laboratory-Developed Tests

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.This guide converts the requirement complexities of US Food and Drug Administration (FDA) regulations into plain language, offering intuitive assistance on how to conform to the Quality System Regulation (QSReg), 21 CFR 820, when creating laboratory-developed tests (LDTs). This CLSI practical guide can help laboratorians learn how to address the new demands, beyond the Clinical Laboratory Improvement Amendments (CLIA) regulations, within their unique laboratory settings.

“LDTs are 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 On October 3, 2014, the FDA issued draft guidance for regulating LDTs that includes notification or registration of LDTs with the FDA, reporting adverse events, and other requirements.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 of LDTs when the final guidance is published.”

To purchase this guide for your laboratory, visit the CLSI website.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s