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, 2024β€’12 min
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Episode description

π—‘π—˜π—ͺ𝗦 β†’ 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:


βœ… The 4-year phase-in timeline for compliance


βœ… Expanded enforcement discretion for certain LDTs


βœ… 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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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices | Device Advice by RQM+ podcast - Listen or read transcript on Metacast