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March 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 in diagnosis and patient management Laboratories offering LDTs continue to file initial public offerings (IPOs) Given the pace of technological change and innovation, this trend towards ...

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