Stay current with FDA requirements for laboratory developed tests (LDTs) following the vacatur of the May 2024 amendment to 21 CFR 809.3(a). This course details the regulatory reversion, compliance expectations, and significant cost savings resulting from the court’s decision. Learn exactly what has changed, what is required for ongoing compliance, and the impact for your organization. Ensure your policies and procedures align with the pre-May 2024 framework and be prepared for enforcement from September 19, 2025 onward.
In this course you will learn the following:
* Understand the regulatory background and the court decision leading to the vacatur.
* Identify the specific changes to 21 CFR 809.3(a) and related statutory citations.
* Recognize the compliance requirements and effective date of the reverted regulation.
* Assess the economic implications and cost savings resulting from the vacatur.
* Understand the consequences of non-compliance with the reverted regulation.
