FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing

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. Multiple lawsuits were brought against the FDA and consolidated before a district court in the Eastern District of Texas….
By: Womble Bond Dickinson