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Home » Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests
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Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests
As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks — including hundreds in opposition that are identical — that strongly diverge on whether the proposed rule will ensure test reliability or will burden labs with red tape and reduce the availability of tests for infectious diseases.