CLSI LDT Foundations Webinar Series
Be Prepared for the US FDA Rulings on LDTs
This webinar series is dedicated to the US FDA's May 2024 Final Ruling which declared the administration's authority to regulate laboratory developed tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA) and phases out the discretionary enforcement that has been in place since the law was first enacted in 1976. There are five phase-in stages for this oversight, and the first is scheduled to take effect May 2025.
The webinar series includes live panel discussions and on-demand recordings and is designed to provide practical guidance, resources, and vital information for laboratories navigating the new regulation.
CLSI will continue to update this series frequently with new webinar updates and topics and other LDT resources. Be sure to check back for new offerings!
This webinar series is dedicated to the US FDA's May 2024 Final Ruling which declared the administration's authority to regulate laboratory developed tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA) and phases out the discretionary enforcement that has been in place since the law was first enacted in 1976. There are five phase-in stages for this oversight, and the first is scheduled to take effect May 2025.
P.A.C.E. Information
Earn 1.0 P.A.C.E.® credit for each session.
Featured Webinars
Webinar 1
LDT Foundations: An Overview of FDA's Final Rule on LDTs
Panel discussion and overview of the FDA's Final Rule on LDTs, including practical resources for your laboratory to implement into practice.
Webinar 2
LDT Foundations: Standards to Prepare for Stage 1 Requirements
A focus on the first phase requirements including corrections and removals, medical device reporting, and complaint handling.
Webinar 3
Navigating Design Controls for LDTs
A discussion around navigating design controls for FDA's Final Rule on LDTs, including resources for your laboratory to implement into practice.
Bonus Webinar
Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories
Recorded on: Wednesday, 28 August 2024
The appropriate use of consensus standards can greatly streamline FDA medical device submissions and reduce the burden for the conformity assessment elements. With appropriate use of FDA-recognized consensus standards, developers of devices and LDTs can submit declarations of conformity (DOC) to meet some premarket requirements and reduce the amount of supporting data and information that are submitted to FDA.
Related Resources
CLSI's LDT Perspective
The FDA Ruling on LDTs: Taking Control of What's in Your Control
Since the final FDA ruling on Laboratory Developed Tests was published on 06 May 2024, there has been a great deal of discussion around the interpretation and implications of the new oversight. The final ruling declares the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA) and phases out the discretionary enforcement that has been in place since the law was first enacted
in 1976.
CLSI EPLDT Quick Guide
Validating Performance Claims for Laboratory-Developed Tests, 1st Edition
This quick guide helps users navigate CLSI Evaluation Protocol documents that address the Validation Phase of the Test Life Phases Model.
