What the FDA's Final Rule Means for the Future of Laboratory Developed Tests

Last week, the U.S. FDA issued their long-awaited, groundbreaking 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 monumental operational changes and increased costs for LDT manufacturers, laboratories, and academic medical centers.

The ruling will seek to phase out the current enforcement discretion approach for LDTs and instead reclassify these tests as in vitro diagnostic (IVD) devices subject to lengthy and costly FDA pre-market reviews. While the broad strokes of this rule and its impact were debated by stakeholders during its proposal phase, what are the steps labs should be taking now as this regulatory shift is implemented in the coming years?

Join us at 12:00 p.m. EDT, Thursday, May 16, as we welcome attorneys Gail H. Javitt and Jeffrey N. Gibbs of FDA law firm Hyman, Phelps & McNamara, and “FDA Law Blog”, to dive into details of the final rule and its timeline for implementation. Don't miss this chance to get an early breakdown of this significant regulatory shift so your lab can prepare and remain compliant with the changes to come.

The FDA is also hosting a webinar on the LDT Final Rule and Commissioner Califf will be speaking at the FDLI Annual Meeting. We’ll be covering these events and will break down in our webinar any interesting new developments.

We will review:

• Significant changes between the proposed and final rule.
• How the current enforcement discretion approach for LDTs will change.
• A timeline for the rollout of the rule's five phases.
• Questions surrounding pre-market submissions and test complexity.
• Q&A