In early May, 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?
We recently welcomed 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.
We review:
-Speaker intros (0:30)
-Overview of the issue (5:25)
-FDA's justification and rationale (6:26)
-What changed in the Finale Rule (9:25)
-Review of phase-out policy (10:54)
-Scope of LDT enforcement and LDT classification (17:45)
-Defining "enforcement discretion" (20:45)
-Public comments and implementation into Final Rule (21:56)
-Major themes of comments (23:19)
-Response from FDA (28:25)
-Outstanding questions (29:35)
-What should labs do now? (31:25)
-Conclusion (32:37)
-Q&A (35:19)
9 сен 2024
