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Are You Looking for Information Regarding FDA Proposed Requirements for Laboratory-Developed Tests (LDTs)?

Find the Guidance to Quick Start Compliance Preparedness

You have likely seen the FDA’s recent announcement explaining its proposal to issue new guidance to clinical laboratories and manufacturers that develop LDTs—but you may not yet know exactly how to address the new demands, specifically for the Quality System Regulation (QSReg), 21 CFR 820, within your unique laboratory setting.

CLSI Puts FDA Requirements in Practical Terms

We know that it can difficult to navigate the complexities of the FDA’s new proposed guidance. That is why we are providing you with helpful resources to answer some of the most commonly asked questions, and to help you understand what will be now be suggested for laboratories running LDTs, above and beyond what is already done for CLIA.

Explore Helpful LDT Resources

Access the FDA Announcement

Read the full notice issued by the FDA to Congress, which details both the Guidance Framework it is proposing for oversight of LDTs, as well as the risk-based, phased-in approach it plans to take to implement these changes.

fda announcement

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Quick Start Compliance Preparedness With Our Helpful Q&A Guide

What processes and procedures could be impacted by the FDA’s QSReg? What types of LDTs will they focus on? How can we prepare?

To help answer these important questions, we have summarized the most critical points you need to know to keep your laboratory on track for the changes.

q&a guide

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Learn How to Be Fully Prepared

Our LDT infographic summarizes key information on what the FDA regulations may mean for your laboratory, when the proposed guidance goes into effect, and how you can efficiently prepare.

LDT infographic

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Use CLSI’s GUIDE to Practically Prepare

CLSI has created a practical guide that converts the requirement complexities of new FDA regulations into plain language, offering intuitive guidance on how to conform to the Quality System Regulation (QSReg), 21 CFR 820.

Quality System Regulations for Laboratory Developed Tests: A Practical Guide for the Laboratory

Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory

Developed by experts in complying with FDA regulations and succeeding with FDA inspections, this document translates the requirements around FDA proposed requirements for high-risk LDTs into intuitive, actionable steps to prepare for the change. You will:

  • Learn where the QSReg differs from current CLIA requirements, and how it affects your protocols.
  • Find tips and hints on methods for complying that have been proven to be effective.



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