FDA Notifies Congress that It Will Regulate LDTs

CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tests that are used by healthcare professionals …

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FDA Notifies Congress that It Will Regulate LDTs

Federal agency proposes risk-based oversight for 2,000 clinical laboratories offering 11,000 LDTs

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