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Public, Academic Labs Press FDA To Be Flexible In LDT Requirements

State health and academic labs ask FDA to exercise flexibility in its clinical requirements for laboratory-developed tests and warn against unintended consequences for public health testing.

Public and academic laboratories are asking FDA to permit more flexibility and more limited clinical trials to prove the clinical utility of laboratory-developed tests (LDTs) than the agency allows for other devices.

The advice comes amid the heavy volume of feedback that FDA received in written responses to its proposed framework for actively regulating LDTs, issued in the form of draft guidance...

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