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111: FDA and LDT's what does it actually mean for the labs? Kitchen chat w/ Dr. Thomas Nifong
21:52
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2024/10/19
Digital Pathology Podcast
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Introduction and Special Guest Announcement
What Does the FDA's New Rule on LDTs Mean for Labs?
A Casual Lunch Conversation
Understanding FDA's Authority Over Medical Devices
Disputes and Legal Challenges to the FDA's Rule
Practical Implications and Industry Reactions
The Role of CMS and Medical Necessity
Impact on Labs and Future LDTs
Quality Systems and Compliance
Modifications and Software Updates
Conclusion and Next Steps
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