FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices - podcast episode cover

FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices

Apr 30, 202412 minTranscript available on Metacast
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Episode description

𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨


RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including:


✅ The 4-year phase-in timeline for compliance


✅ Expanded enforcement discretion for certain LDTs


✅ Grandfathering clause for currently marketed LDTs


Watch now to learn how this rule impacts your business and what steps you need to take to ensure compliance.


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