Laboratory Developed Tests: What to Expect in 2025 and Beyond
The laboratory industry was upended earlier this year with the release of FDA’s LDT final rule, which officially began the phaseout of the Agency’s long-standing enforcement discretion. This webinar will provide actionable regulatory insights to help you prepare for next year and the years to come.
Time & Location
Dec 04, 2024, 12:00 PM – 1:00 PM MST
Live Webinar
Event Overview
The FDA’s final rule on laboratory developed tests presents a significant paradigm shift in laboratory operations and their compliance obligations. For decades, laboratories have operated outside of FDA regulation. Beginning in 2025, that “exemption” is set to expire. The long-standing enforcement discretion will be phased out in five phases, with the first deadline in May 2025. However, numerous enforcement discretion and exemption policies remain in place, and it can be difficult to navigate the complexities of these policies and stay on the right side of the line between compliance and non-compliance if laboratories wish to follow one of these policies. It's imperative to fully understand the phaseout process, and exactly what laboratories need to comply with and when. Not only does a company’s laboratory operations depend on the correct interpretation and implementation of the regulations, but patients and providers served do as well.
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