Shuren: LDT Reliability Critical To Precision Medicine Initiative
This article was originally published in The Pink Sheet Daily
The head of FDA's device center said the agency's efforts to oversee laboratory developed tests are critical to ensuring reliability of genetic tests in conjunction with the president's Precision Medicine Initiative.
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ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.
Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.
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