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

Device Advice by RQM+

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15d ago 12:17

MP3•Episod hem

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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