PORTLAND Ore. (KPTV) - Jeri was surprised when her OB/GYN office was calling her on February 1. It had been a year since her last exam when they told her there was nothing to worry about. The phone ...

Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same ...