Devices

Agencies Launch Emergency Diagnostics Task Force

FDA is joining the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services to launch a tri-agency task force to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies. An FDA media release says each of the three agencies plays a critical role in responding to public health emergencies, including identifying threats, regulating medical products, and providing oversight for laboratories.

Prior to this partnership, the release says, feedback from the clinical laboratory community indicated that there was uncertainty about how to implement the diagnostic tests once they received an emergency use authorization (EUA) from FDA. In particular, it says, the community was uncertain about meeting CLIA regulations under an EUA to allow labs to start testing specimens.

“By standardizing collaboration efforts,” FDA says, “the federal partners hope to address issues related to implementation of diagnostic tests authorized for emergency use under an EUA, as well as other unmet needs and gaps in preparing and responding to global health threats. The task force will provide a forum for each agency to coordinate, provide consultation, and improve the availability of diagnostic tests during public health emergencies. In addition, to assist public health preparedness, the task force will work to define, refine, and streamline interagency approaches for the implementation of EUA diagnostic tests. The hope is that the task force will enable an even more efficient federal government response for making diagnostic tests available in the event of a public health emergency.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome