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.
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.
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.
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.
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.
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.
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: