Four unanswered questions about the looming LDT regulations

The FDA described the contents of its proposed regulatory framework to Congress, but the details of its plan remain a mystery. Following the July 31 notification to Congress, the agency must wait at least 60 days before the release of its draft guidance on the topic. The Coalition for 21st Century Medicine released four questions about the FDA's plan that it says still need answering. They asked how the FDA labeling requirements apply in the absence of a distributed or tangible box on which to put a label; how the FDA will decide which laboratory activities it can regulate, and which are "the practice of laboratory medicine"; how the FDA's rules on test design and quality systems apply to laboratories; and how the agency will manage conflicting regulatory requirements with respect to consultations with physicians about patient test results. The Coalition for 21st Century Medicine comprises many leading diagnostics companies such as Myriad Genetics ($MYGN) and Foundation Medicine ($FMI). Release

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