Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
LDT and IVD Info Hub
!!UPDATE MAR 31, 2025 - The LDT Final Rule was overturned in court!! Get more info from ACLA ---------------------- From October 2024 ------------------------------- Summary of the issue: FDA announced new actions to strengthen the safety and effectiveness of...
LDT 5 Stages of Grief
Quite a few LDT companies are in the Anger and Denial phases, while some have progressed to Bargaining. The companies that are poised for success though are already in the Acceptance phase and moving forward with developing their QMS. It is likely that the final rule...