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FDA’s final rule on LDTs: What this means for laboratories
Understand how the FDA’s new rules on Laboratory Developed Tests (LDTs) impact laboratories and their compliance with device regulations.
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key takeaways
What you will learn
- Learn which labs are now considered device manufacturers by the FDA
- Discover how labs can begin compliance preparations for Stage 1 of the phased rollout
- Understand the regulatory processes and system requirements to meet FDA compliance for LDTs.
About this webinar
Navigating FDA’s LDT final rule: Impact on laboratories
This session offers a deep dive into the FDA's final rule regulating LDTs as medical devices. Regulatory attorney Christine Bump explains how labs can navigate the new requirements, including understanding FDA exemptions and preparing for compliance stages. You will leave with practical advice for maintaining regulatory standards under the new LDT rule.
Christine P. Bump
Principal and Founder Penn Avenue Law & PolicyChristine Bump brings over 20 years of experience guiding labs through FDA regulations, advising on diagnostics, health platforms, and genetic testing. As the principal of Penn Avenue Law & Policy, she advises large organizations on compliance and strategic regulatory goals.
Christine P. Bump
Principal and Founder Penn Avenue Law & PolicyChristine Bump brings over 20 years of experience guiding labs through FDA regulations, advising on diagnostics, health platforms, and genetic testing. As the principal of Penn Avenue Law & Policy, she advises large organizations on compliance and strategic regulatory goals.
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