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

Video Transcription

Video Summary

The town hall hosted by ASAP provided an in-depth overview of the FDA's final rule on laboratory-developed tests (LDTs). Moderated by Chris Tormey from Yale's Department of Laboratory Medicine, the event featured expert panelists Dr. Jonathan Genzin, Dr. William G. Finn, and Ms. Michelle Campbell. They detailed the new regulations, which mark a significant shift in FDA oversight of LDTs from enforcement discretion to formal regulation.<br /><br />The FDA's final rule introduces a phased timeline, with Stage 1 starting in May 2025, requiring compliance with medical device reporting and other basic quality system requirements. Subsequent stages add requirements such as registration, labeling, and more complex quality system controls, culminating in pre-market review submissions for high-risk and then moderate-risk tests by May 2028.<br /><br />Key exceptions and categories where targeted enforcement discretion will apply include 1976 type LDTs, HLA testing for transplants, and tests for law enforcement or forensic purposes. Current LDTs on the market and those addressing unmet medical needs have specific compliance exemptions but must meet certain record-keeping and other limited requirements.<br /><br />The town hall also discussed practical concerns, outlining the significant logistical and financial impacts these regulations might have, particularly on smaller laboratories. The presenters emphasized the importance of staying informed and potentially seeking FDA clarification on specific nuances, such as the submission process and allowable modifications.<br /><br />ASCP plans to offer ongoing education and resources to help laboratories navigate these new regulatory requirements, underscoring the opportunity for continuous engagement and learning among professionals in the field.

Keywords

FDA final rule

laboratory-developed tests

Chris Tormey

regulations

compliance

medical device reporting

logistical impacts

ASCP

education resources