Join Us for an HPM/Lighthouse Labs Webinar: What the FDA’s Final Rule Means for the Future of Laboratory Developed Tests; Thursday, May 16, 2024: 12:00-1:00 PM EDT

May 15, 2024

On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests (LDTs). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring significant operational changes and posing strategic challenges for many LDTs. The final rule also created exemptions for some other LDTs.

Join us at 12:00 p.m. EDT, Thursday, May 16, as Hyman, Phelps & McNamara, P.C. attorneys Gail H. Javitt and Jeffrey N. Gibbs—in conjunction with Jon Harol of Lighthouse Labs—dive into details of the final rule and its timeline for implementation. Don’t miss this chance to get a breakdown of this significant regulatory shift and its implications.

In this webinar you’ll learn:

  • Significant changes between the proposed and final rule
  • How the current enforcement discretion approach for LDTs will affect you
  • A timeline for the rollout of the rule’s five phases
  • Get your questions answered by the experts during the live Q&A

Don’t delay, click here to register today!