FDA Drops Guidances For LDTs

On Friday, November 18, 2016, the Obama Administration announced it was dropping its plan to regulate Laboratory Developed Tests (LDTs) by finalizing two FDA proposed Guidances published on October 3, 2014.

According to the FDA, a decision on how to regulate LDTs will be left to the newly elected Congress and the Trump Administration.

"We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access to 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," said FDA spokeswoman Tara Goodin.