NOVEMBER 13, 3:30 PM ET
Though some questions have been answered since the FDA released its final rule on lab-developed test (LDT) regulation in early May 2024, there’s still much uncertainty for labs around compliance, even as we approach the first deadlines. With the FDA facing two separate lawsuits challenging its authority to regulate LDTs, a search ongoing for a new director of the Center for Devices and Radiological Health, and the US election looming, many lab leaders are wondering if the new rule will even proceed.
In this panel discussion, regulatory experts Shannon Bennett, Julie Ballard, and Sheila D. Walcoff, JD, address key questions remaining about LDTs and how labs may wish to address compliance amidst such uncertainty. Attendees will also have the opportunity to submit their most pressing questions related to LDTs regulation.
Speakers:
Shannon Bennett
Director of Regulatory Affairs, Department of Laboratory Medicine and Pathology
Mayo Clinic
Julie Ballard
Principal
Carrot Clinical
Sheila D. Walcoff, JD
CEO and Founder
Goldbug Strategies
Note: You only need to register once to be signed up for all of the November 2024 Lab Institute talks. View the full event agenda at https://www.g2intelligence.com/lab-institute-virtual-event-advancing-the-profession-of-diagnostic-medicine-2024/.
This webinar is sponsored by Today’s Clinical Lab, partner brand of G2 Intelligence.
