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Home » GAO sees need for more clarity in FDA enforcement discretion for pandemic tests
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GAO sees need for more clarity in FDA enforcement discretion for pandemic tests

May 16, 2022
By Mark McCarty
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
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