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Friday, January 28th, 2022

New joint task force collaborates on rapid development of diagnostic tests for emergencies

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Recognizing the potential for public health emergencies to be exacerbated by lack of cooperation, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) have created a joint task force to make diagnostic tests more rapidly available.

The task force uses resources from each agency to manage the rapid development and deployment of such tests during emergency situations. Alone, each agency has a part to play during such crises, but it is together they react and halt them. Threat identification, medical product regulation, laboratory oversight — each is important, but unless working together, it is unlikely any one piece could solve such a crisis.

Further complicating matters was the fact that prior to this task force, responses from clinical labs showed that many found it unclear how to implement diagnostic tests once given an Emergency Use Authorization (EUA).

“We’re all in this together,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said. “To that end, the FDA knows that collaborating with our federal partners to employ our collective expertise, experiences from previous incidents, and resources will better assist in a global response. We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies’ coordination. This task force will help our agencies better collaborate to prepare for, and respond to, public health threats, including identifying threats and ensuring the appropriate diagnostics are in place to support efforts in the field.”

The FDA issues EUAs for use of diagnostic tests and the CDC provides expertise to respond to such emergencies. The CMS provides guidance to guarantee accurate, reliable and timely results in the nation’s labs. The task force, therefore, aims to standardize these efforts and make implementation more seamless in times of crisis. It will also refine and simplify interagency efforts during EUA diagnostic test implementation.