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Mar 26, 2014

FDA and LDTs—What’s Next?

The Administration is claiming power over laboratory-developed tests. However, the lab industry disagrees.

FDA and LDTs—What’s Next?

The FDA, for over twenty years, has asserted that it has authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. [© inkaone - Fotolia.com]

  • Laboratory-developed tests (LDTs) continue to proliferate. Companies are regularly announcing the introduction of new LDTs, and these tests are playing a more important role ...

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