FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices
Episode description
π‘ππͺπ¦ β FDA releases final rule on Laboratory-Developed Tests (LDTs) π¨
RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including:
β The 4-year phase-in timeline for compliance
β Expanded enforcement discretion for certain LDTs
β 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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