The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) By Jeffrey N. Gibbs & Allyson B. Mullen —

https://www.thefdalawblog.com/2024/05/the-end-of-a-long-and-winding-road-fda-publishes-final-ldt-rule-or-is-it/?utm_source=rss&utm_medium=rss&utm_campaign=the-end-of-a-long-and-winding-road-fda-publishes-final-ldt-rule-or-is-it On April 29, 2024, FDA announced its finalization of the laboratory developed test (LDT) rule. The final rule will be published in the Federal Register on Monday May 6, 2024 (here). The final rule marks another milestone in the more than three decades long battle over LDTs. FDA notes that it received over 6,500 comments on the proposed rule. Showing how motivated FDA was to quickly finalize the rule, the Agency claims to have reviewed and addressed all major issues they raised in less than 5 months.