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Preparing for Implementation of FDA's Laboratory-Developed Test Final Rule

May 23, 2024

The CAP held a webinar focused on the Food and Drug Administration’s (FDA) laboratory-developed tests (LDT) final rule. Over 1,300 members registered and close to 1,000 members attended the event which featured CAP President Donald Karcher, MD, FCAP; Council on Government and Professional Affairs Chair Joe Saad, MD, FCAP; and Council on Scientific Affairs Chair Bobbi Pritt, MD, MS, FCAP. The presentation and discussion offer insights into the CAP’s initial analysis of the regulation, the timeline for implementation, the impact on laboratories and advocacy efforts around the regulation. Presentation slides are available for download here.

This is the first in a series of webinars and resources that the CAP will provide to members to help prepare for implementation of the rule in the months and years to come. The CAP is committed to meeting the needs of our members and advocating for the least burdensome regulation on pathologists. For the most updated information on LDT’s visit Regulatory Updates.