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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices
Manage episode 415487456 series 2688337
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.
-
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
172 епізодів
FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices
Manage episode 415487456 series 2688337
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.
-
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
172 епізодів
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