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What does the FDA jurisdiction for LDTs mean for the labs? Do they need to worry? How do they need to change the way they operate?In this episode, I talk with Dr. Thomas Nifong, a clinical pathologist and VP of CDX operations at Acrovan Therapeutics, about the recent FDA ruling on laboratory-developed tests (LDTs) issued on May 6th, 2024. We discuss the implications of considering LDTs as medical devices, requiring regulation, and explore the authority of FDA versus CLIA. The conversation also covers historical contexts, practical implications of regulatory changes, and the roles of organizations like CAP, ACLA, and AMP in legal challenges against the FDA. We dive into the differences in requirements between CLIA and FDA, New York's alternative approval route, and potential impacts on lab operations and compliance. Join us for an insightful conversation filled with essential information for those in the field of molecular pathology.00:00 Introduction and Special Guest Announcement00:24 FDA's New Rule on Laboratory Developed Tests (LDTs)01:58 Recording the Podcast: A Casual Lunch Conversation03:47 Understanding FDA's Authority Over Medical Devices08:07 Disputes and Legal Challenges12:03 Practical Implications and Industry Reactions12:47 Understanding FDA's Focus: Safety and Efficacy14:11 The Role of CMS and Medical Necessity14:48 Congressional Involvement and Legal Authority16:06 Impact on Labs and Future LDTs18:33 Quality Systems and Compliance20:16 Modifications and Software Updates21:16 Conclusion and Next Steps
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