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FDA Notifies Congress of the Proposed Regulatory Oversight of Laboratory Developed Tests

05 August 2014

Medical Device Alert

On July 31, 2014, the U.S. Food and Drug Administration (FDA or the Agency) announced plans to formally regulate laboratory developed tests (LDTs). The announcement came in the form of letters to Congress attaching the preliminary drafts of two guidance documents describing the Agency's proposed risk-based framework for regulatory oversight of LDTs.

Read More: FDA Notifies Congress of the Proposed Regulatory Oversight of Laboratory Developed Tests

The team

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