TNHLLDTS2024 - CME/CMLE - Virtual Town Hall: An Overview of the FDA’s Final Rule on Laboratory Tests-An Overview of the FDA's Final Rule on Laboratory Tests

An Overview of the FDA's Final Rule on Laboratory Tests - Virtual Town Hall

Pdf Summary

The Virtual Town Hall held on May 21, 2024, provided a detailed overview of the FDA’s final rule on laboratory developed tests (LDTs). Moderated by Jonathan R. Genzen, the session included notable faculty members who discussed the implications of the new regulations on laboratory tests.<br /><br />The session emphasized that the views presented do not represent the FDA or their employers, and the interpretations discussed are not medical or compliance advice. The major topics of the webinar included the requirements of the final rule, deadlines, applicable quality system requirements under the rule, and potential impacts on laboratories moving forward.<br /><br />A brief history of regulatory actions on LDTs from the 1976 Medical Devices Amendments to the 2023 proposed rule, leading to the 2024 final rule, was provided. The webinar highlighted the American Society for Clinical Pathology (ASCP)'s advocacy efforts, including meetings, policy statements, and comments on various regulations over the years.<br /><br />The final rule categorizes LDTs as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It introduces phased enforcement discretion policies, transitioning from a general enforcement discretion approach. The phase-out spans from Stage 1 (medical device reporting starting May 6, 2025) to Stage 5 (premarket review for moderate and low-risk LDTs by May 6, 2028).<br /><br />The rule specifies three major groups exempt from oversight:<br />1. LDTs pre-1976<br />2. Human leukocyte antigen tests for transplant<br />3. Tests used solely for law enforcement.<br /><br />It introduces specific requirements for LDTs currently on the market, modifying other IVDs, and LDTs for unmet medical needs within healthcare facilities.<br /><br />Polls during the webinar gauged participant concerns about the impact on patient access to lab tests, confidence in compliance, and laboratory preparedness for premarket review requirements. Participants were encouraged to provide feedback to inform future educational initiatives, with instructions for obtaining Continuing Medical Education (CME) or Continuing Medical Laboratory Education (CMLE) credit to be emailed subsequently.

Keywords

Virtual Town Hall

FDA final rule

laboratory developed tests

Jonathan R. Genzen

regulations

quality system requirements

American Society for Clinical Pathology

Federal Food, Drug, and Cosmetic Act

phased enforcement discretion

premarket review