!!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...
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...