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The U.S. Food and Drug Administration’s rule on laboratory developed tests — What it means for you

View the slide deck here.

Description

Approximately 12,000 laboratories in the United States are eligible to perform laboratory developed tests (LDTs). LDTs meet a vital need in the healthcare system, often serving as the only means of identifying rare medical conditions or providing invaluable information to clinicians when existing U.S. Food and Drug Administration (FDA) cleared or approved tests do not provide the data needed to diagnose and treat a patient.

The FDA published a final rule on May 6, 2024, which extends agency oversight to laboratory developed tests. Clinical laboratories performing such tests will be considered medical device manufacturers for regulatory purposes. Many Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) members perform LDTs as part of their job, including developing the tests, verifying and overseeing their performance, and reporting the patient results. The agency rule will significantly impact the ability of our members and their institutions to offer these tests.

This webinar will explain the FDA’s new rule to regulate LDTs, including the scope and intent of the document, the new regulatory requirements, exceptions, and the timeline for implementing the rule. In addition, our speakers will highlight the decisions that laboratories will need to make and the timeframe for doing so. The speakers will also provide a status update on the outside forces that may affect the trajectory of the rule.

Join our experts to learn the importance of this regulation, how it may affect your laboratory, and the decisions you will need to make.

Please note that this webinar is not available for ACCENT credit.

Faculty

The intent and scope of the rule and the key aspects you need to know

Stephen R. Master, MD, PhD, FAACC Stephen Master, MD, PhD
Division Chief and Director of Metabolic and Advanced Diagnostics
Children's Hospital of Philadelphia

Dr. Stephen Master, MD, PhD, Division Chief and Director of Metabolic and Advanced Diagnostics at Children's Hospital of Philadelphia will outline the purpose behind the rule and identify key areas of interest to laboratories, including the new requirements, exceptions, and limitations associated with those exceptions.

The regulatory framework and the decisions you need to make

Jonathan Genzen, MD, PhD
Chief Medical Officer, Senior Director of Governmental Affairs,
Professor of Clinical Pathology (Clinical)
ARUP/University of Utah

Dr. Jonathan Genzen, MD, PhD, Chief Medical Officer, Senior Director of Governmental Affairs, Professor of Clinical Pathology (Clinical), University of Utah will describe the FDA’s implementation timeframe for the rule as well as the types of decisions that labs will need to make at each stage of the process. Dr. Genzen will further discuss the resources and staffing issues that laboratories will need to take into consideration as they assess this rule.

Target audience

This activity is designed for laboratory directors, laboratory supervisors, laboratory managers (supervisory and/or non-supervisory), clinical laboratory scientists, and other laboratory professionals involved in oversight and testing.

Learning objectives

At the end of this activity, participants will be able to:

  • Describe the rule and its implications for laboratories performing LDTs.
  • List the requirements detailed in the rule and the potential exceptions.
  • Identify the implementation timeframe and the decisions labs will need to make.
  • Recognize potential legal and legislative actions that may affect the implementation of the rule.

Resources