On September 18, 2016, FDA announced that it would wait for the new administration before issuing the guidance documents to end enforcement discretion of laboratory developed tests (LDTs). LDTs are tests developed and conducted in a single laboratory. Historically, they were simple tests with little or no impact on public health. In recent years, they have become more complex and more widely used prompting FDA to bring them under regulatory control.
FDA announced, “FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”