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Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies

 
• By Elizabeth Orr

The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used. 

MT2005_Rapid COVID_19 Test_1686420460_1200.jpg
• Source: Shutterstock

The US Food and Drug Administration succeeded in getting COVID-19 tests into the hands of consumers quickly during the pandemic but should develop a policy for the use of enforcement discretion to better regulate diagnostics during any future pandemics.

That is the conclusion reached by the Government Accountability Office (GAO) in a new report titled “FDA Took Steps...

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