Lab-Developed Tests Under New FDA Oversight – Key Changes Ahead
- Author
- Womble Bond Dickinson
- Published
- Thu 30 Jan 2025
- Episode Link
- None
Today, we’re breaking down a pivotal change in the regulatory landscape for Lab-Developed Tests—or LDTs. These tests are a vital part of modern healthcare, used every day for diagnosing and managing diseases, monitoring treatments, and more. Think COVID-19 tests, blood glucose testing, or even genetic screening like HIV or HPV testing.
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FDA Broadens Oversight of Lab-Developed Tests
About the authors
Jennifer Housden, RN, BSN*
L. Christine Lawson
