FDA Releases LDT Regulatory Framework, Notification Draft Guidances
This article was originally published in The Gray Sheet
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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A US FDA spending bill approved by the House Appropriations Committee July 12 would halt finalization of the agency's draft 2014 laboratory developed test guidance, recommending that FDA let Congress write its own bill directing any LDT regulation – but FDA already essentially handed the LDT reins to lawmakers last January.
After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.
FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.