CLSI QSRLDT

Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory, 2nd Edition

This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part

CLSI EPLDT Quick Guide

Validating Performance Claims for Laboratory-Developed Tests, 1st Edition

This quick guide lists CLSI Evaluation Protocol documents that cover the Validation Phase of the Test Life Phases Model.

CLSI M100 2025 Update Webinar

Implement CLSI M100 With Confidence

Join CLSI on Wednesday, February 26 at 1:00 ET for a webinar on the latest in Antimicrobial Susceptibility Testing (AST) with the release of CLSI M100 Ed35. Receive the latest guidance for implementing new breakpoints and standards into your laboratory practices, including discussion of the major changes in this edition

CLSI On-Demand Regulatory Webinar

Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories

Navigating the FDA device approval and clearance process can be daunting. However, the appropriate use of consensus standards can greatly reduce the burden for the conformity assessment elements of medical device submissions. By using declarations of conformity (DOC), particularly with FDA-recognized standards, device developers and manufacturers can streamline submission preparation. The session will provide direction on how stakeholders can – and should – contribute to the development of conse

CLSI On-Demand EP 2024 Webinar

What's New in Method Evaluation?

Participate in this CLSI webinar to gain knowledge about the latest method evaluation standards, get a sneak peek of EP47, and engage in a Q&A session addressing important topics in the industry.

CLSI On-Demand LDT Webinar 1

LDT Foundations: An Overview of FDA's Final Rule on LDTs

Join CLSI for this webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register for this first webinar and receive access to the entire series, which will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, to

CLSI On-Demand LDT Webinar 2

LDT Foundations: Standards to Prepare for Stage 1 Requirements

CLSI On-Demand LDT Webinar 3

LDT Foundations Webinar Series: Navigating Design Controls for LDTs

Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). The third webinar is a discussion around navigating design controls for FDA's Final Rule on LDTs, including resources for your laboratory to implement into practice. The webinar will include guidance around design controls, a highlight of useful resources, and a Q&A discussion.