FDA Resumes Move to Regulate LDTs, Likely Setting up Legal Battle With Lab Industry

The US Food and Drug Administration is moving to regulate laboratory-developed tests (LDTs), setting up a potential legal battle with the lab industry.

In remarks at the American Clinical Laboratory Association’s annual meeting this month, Elizabeth Hillebrenner, associate director at the FDA’s Center for Devices and Radiological Health, said the agency is advancing plans to regulate LDTs through the rulemaking process.

Source: https://www.360dx.com/regulatory-news-fda-approvals/fda-resumes-move-regulate-ldts-likely-setting-legal-battle-lab#.ZBNu9nbMKUk