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Regulatory Focus™ > News Articles > 2019 > 2 > FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

Posted 26 February 2019 | By Ana Mulero 

FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

Three US Department of Health and Human Services agencies announced Tuesday the launch of the Tri-Agency Task Force for Emergency Diagnostics (TTFED) to better respond to public health emergencies.

With the distinct roles set for each of the agencies, TTFED is intended to leverage the expertise of the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) around the development and deployment of diagnostic tests during public health emergencies. It is charged with advancing a harmonized approach for the availability of in vitro diagnostic (IVD) assays in the US health care system in a timelier manner.

Each agency has committed to bringing their own skill set to the table and improving coordination on consultations and recommendations to facilitate the use of IVDs via FDA’s Emergency Use Authorization (EUA) authority. This authority allows for IVDs without FDA approval or clearance to be released in clinical and public health laboratories for emergency use if the statutory EUA criteria have been met.

FDA, CMS and CDC have historically had their own distinct roles in responding to public health emergencies. These include the regulation of medical devices, providing government oversight of laboratories and identifying emerging or potential threats to public health, respectively. Yet TTFED goes a step further as it was developed with additional specifications on each of the sister agencies’ roles.

TTFED’s scope of activities is three-fold under the agencies’ coordination for rapid deployment and availability. It will “define, refine, and streamline interagency approaches” in advance of an emergency, convene and provide a discussion forum during an emergency and “develop, document and refine processes and procedures to address gaps in the current EUA implementation system” based on the review of a response to a recent emergency. Each member’s focus is also three-fold and centered on communication channels, interagency processes and timely recommendations.

At least one participant from each of agency will comprise TTFED. FDA’s representative(s) will contribute expertise in the regulatory reviews of IVDs and EUA authorities, while CMS’ expertise will cover regulations under the Clinical Laboratory Improvement Amendments Act of 1988 (CLIA). There will also be at least one CDC representative with expertise in IVD development and EUA IVD implementation.

TTFED’s establishment comes after “feedback from the clinical laboratory community indicated that there was uncertainty about how to implement the diagnostic tests once they received an EUA,” FDA noted in announcing the launch. This uncertainty relates to meeting CLIA regulations under an EUA.

The new charter is aimed at not only improving responses to public health emergencies in the US, but also providing greater clarity and consistency to laboratories around application of CLIA requirements for EUA IVDs. The agencies “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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

It will serve as an “ongoing activity with no specified end date” and its standing will be reviewed and approved every five years. TTFED plans to meet twice each year and set other meetings as needed.

Charter

Tags: CDC, CMS, EUA, FDA, IVD, IVDs

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