ASCP 2024: Discover How the LDT Ruling May Affect Your Practice

The Food and Drug Administration’s claim it has authority to regulate laboratory developed tests has been a hot topic for more than a year. ASCP will devote three hours of education to this topic, and how it may affect laboratory medicine and patient care, during a special three-part series on Sept. 5 and 6 at the ASCP 2024 Annual Meeting in Chicago.

Panel Discussion on Regulatory Oversight of Laboratory Developed Tests (LDTs)
Thursday, Sept. 5, 8–9 a.m.
Jonathan Genzen, MD, PhD, FASCP, Chief Medical Officer and Professor of Clinical Pathology at ARUP Laboratories, University of Utah, and Michelle Campbell, MLS(ASCP)CMMBCMSCCM, will lead this first panel discussion and present an outline of the five stages of the requirements established by the FDA, potential strategies to comply with the final rule, and recent updates on litigation and potential future legislation.

In May, the FDA officially released its final rule on oversight of laboratory developed tests (LDTs), describing the phaseout of its general enforcement discretion approach for LDTs. The release of this final rule has raised many questions and concerns, specifically regarding how clinical laboratories may be impacted by the final rule, what the specific requirements of the rule are, and how laboratories should best prepare to comply with these requirements in advance of the respective deadlines for compliance. In this “Meet the Experts” session, Dr. Genzen and Ms. Campbell will moderate an interactive Q&A discussion involving attendees, laboratory leaders, and regulatory colleagues to walk through some of the more challenging aspects of the final rule.

Please join us for this timely, open, and engaging discussion on an issue that impacts all clinical laboratories that perform LDTs. This session offers 1.0 CME/CMLE credit.

Practical Approaches to FDA Stage 1 Requirements to Laboratory Developed Tests
Friday, Sept. 6, 10:45–11:45 a.m.
The final rule on laboratory developed tests (LDTs) released by the U.S. Food and Drug Administration (FDA) in May outlines five “phase out” stages occurring over a 4-year period.  Stage 1 includes the first set of requirements that high-complexity CLIA laboratories will be required to adhere to if they are offering LDTs.  These requirements include 1) medical device reporting, 2) corrections and removals reporting, and 3) quality system requirements specific for handling compliant files.  As the deadline for meeting these requirements – May 6, 2025 – is now less than a year away, it is critically important for clinical laboratories to understand what these requirements are, and more importantly, how they can begin to prepare for them in compliance with the final rule. 

In this session, presenters Dr. Genzen and Ms. Campbell will begin by providing an easy-to-understand outline of the requirements underlying stage 1. They will also share with attendees the specific FDA regulations that define these requirements for additional reference.  Important definitions related to adverse events and medical device reporting will be reviewed, emphasizing areas where specific policies are required under the law.  The speakers will review example medical device reports so that attendees can better understand events where reporting to the FDA will be expected. Lastly, the session will conclude with a brief overview of what to anticipate in preparation for stage 2 of the final rule and beyond. This session offers 1.0 CME/CMLE credit.

Interpreting Laboratory Developed Tests FDA Language
Friday, Sept. 6, 1:15–2:15 p.m.
The presenter will be Prithul Bom, President and CEO of Regulatory Technology Services, the FDA accredited Third Party Review Organization. Check back for more details on this session!

Register for the ASCP 2024 Annual Meeting here.

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