In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices

August 1, 2014 4:38 PM

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The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs).

Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a premarket notification [510(k)] application t...

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