Phase I of the LDT was scheduled to be implemented on May 6, 2025. But in a stunning turn of events, on March 31, 2025, a United States District Court set aside and vacated the FDA's Final LDT Rule. This decision upended years of regulatory planning and sparked immediate debate across the diagnostics industry, laboratories, and healthcare providers. How did this happen? What does this mean going forward? Join us to learn about why the Lab developed tests became a hot button regulation in industry to begin with, how the courts were able to invalidate the rule and why this is important.
LDTs, which are tests designed, manufactured, and used within a single laboratory, have long operated under an "enforcement discretion" framework, meaning the FDA historically did not actively regulate them. However, concerns over test accuracy, reliability, and patient safety-especially following high-profile diagnostic failures during the COVID-19 pandemic-led the FDA to propose a phased approach to bring LDTs under its regulatory oversight.
The court's decision to vacate the LDT did not come out of nowhere. Legal challenges argued that the FDA lacked explicit statutory authority from Congress to regulate LDTs as medical devices. Critics of the rule, including lab industry groups and some lawmakers, contended that the existing oversight under the Clinical Laboratory Improvement Amendments (CLIA) was sufficient and that additional FDA regulation would stifle innovation, increase costs, and reduce patient access to essential tests.
The court's decision creates immediate uncertainty. How will labs react, will congress step in, and what about investment in LDT's? Ultimately, as an industry, how will this impact us and why should we care?
Join us as we break down the legal, regulatory, and practical fallout of this landmark decision-and what it means for the future of diagnostics.
Agenda:
- Welcome & Introduction- (5:30 – 5:40 PM) Marielle Lejcher, President at ZoaDx, Sr. Director RA/QA at CovarsaDX
- The Demise of the LDT Final Rule - (5:40- 6:05) Aaron Hage, JD, RAC, Sr. Director Legal-Regulatory and Compliance at DuVal & Associates, P.A
- Why was the ruling denied in its entirety.
- LDT Loopholes – (6:05-6:30) Marielle Lejcher
- How have manufacturers contributed to the LDT problem?
- Where do LDT's fit (6:30 – 6:55) Jackie Torfin, MT (ASCP), CEO, QLeaR Advisors
- There are some good LDT's out there – but are there gaps?
- Panel Discussion and Questions (6:55 – 7:30): Aaron, Marielle, Jackie
- What's Next! Future litigation? New legislation? Investor/Developer reactions?
Who Should Attend:
• Regulatory professionals
• Quality professionals
• Laboratory and hospital leaders
Why Attend?
- Learn directly from industry leaders about the how lab developed test regulation will impact the laboratory.
- Understand the nuances between the ISO 15189 and ISO 13485 standards.
- Network with Minnesota's regulatory community.
Don't miss this opportunity-register today at: https://www.raps.org/events/twin-cities-chapter-in-person-event-lab-developed-test-ldt-regulations-and-the-fdas-evolving-landscape
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Lisa Pritchard
VP of Regulatory, Quality, Clinical and Engineering
DuVal & Associates PA
Bloomington MN
United States
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