Summary of the issue: FDA announced new actions to strengthen the safety and effectiveness of Laboratory Developed Tests (LDTs) through stricter regulations and targeted enforcement. Increased FDA Oversight: The FDA is actively working to ensure the safety and...
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...