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

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

Released Tuesday, 30th April 2024
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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices

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

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

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

Tuesday, 30th April 2024
Good episode? Give it some love!
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๐—ก๐—˜๐—ช๐—ฆ โ†’ FDA releases final rule on Laboratory-Developed Tests (LDTs) ๐Ÿšจ


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


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


โœ… Expanded enforcement discretion for certain LDTs


โœ… 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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