Devices

Pandemic Diagnostic Testing Plan Needed: GAO

A roundtable of experts convened by the Government Accountability Office (GAO) says HHS should have a coordinated national approach to diagnostic testing for pandemic threats. A GAO report outlines steps FDA and other HHS units can take to support such an approach.

While the roundtable suggested nearly 100 actions HHS should take to improve diagnostic testing development, deployment, guidance, and data collection for the future, GAO says the experts coalesced around two of the suggested actions:

a national diagnostic testing strategy to establish clear roles and responsibilities to improve collaboration during future public health threats and also help manage risks; and
a diagnostic testing coordinating group that includes all relevant partners to help coordinate diagnostic testing in preparation for, and in response to, public health threats, and also to help maintain and update a national testing strategy.

The report makes these recommendations for FDA:

develop a process for prioritizing the review of diagnostic test emergency use authorization (EUA) requests during an emergency;
assess and, as appropriate, revise FDA guidance for test EUA requests, including determining how to prioritize requests for review; and
develop a policy for using enforcement discretion about the use of unauthorized tests in future public health emergencies.

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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