FDA to regulate lab-developed tests, citing safety issues raised by journalists

Retrieved on: 2024-07-02 20:27:29

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Food and Drug Administration

Clinical pathology

Medical diagnosis

Medical laboratory

COVID-19 testing

FDA Center for Devices and Radiological Health

Laboratory developed test

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FDA to regulate lab-developed tests, citing safety issues raised by journalists. View article details on hiswai:

Summary

The article describes how the FDA's new regulation on laboratory-developed tests (LDTs) will ensure greater safety and accuracy in clinical pathology and medical diagnosis, particularly highlighted by issues during COVID-19 testing. MedTech industry insights are shared, noting potential industry resistance and congressional intervention.

Article found on: healthjournalism.org

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